| Public Health Service Food and Drug Administration |
| Minneapolis District Office Central Region 250 Marquette Avenue, Suite 600 Minneapolis, MN 55401 Telephone: (612) 334-4100 FAX: (612) 334-4142 |
Department of Health and Human ServicesJune 24, 2011
WARNING LETTER
CERTIFIED MAIL
RETURN RECEIPT REQUESTED
Refer to MIN 11 – 34
Nicole D. Nicklow
Chief Financial Officer
National Creative Enterprises, Inc.
12209 Riverwood Drive
Burnsville, Minnesota 55337
Dear Ms. Nicklow:
During an inspection of your firm located in Burnsville, MN, on December 15, 2010, through March 3, 2011, an investigator from the Food and Drug Administration (FDA) determined that your firm manufactures various medical device replacement batteries. Under section 201(h) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. § 321(h), these products are devices because they are intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease, or are intended to affect the structure or function of the body.
This inspection revealed that these devices are adulterated within the meaning of section 501(h) of the Act, 21 U.S.C. § 351(h), in that the methods used in, or the facilities or controls used for, their manufacture, packing, storage, or installation are not in conformity with the current good manufacturing practice (CGMP) requirements of the Quality System (QS) regulation found at Title 21, Code of Federal Regulations (CFR), Part 820.
We received a response from Jennifer Aura, Director of Operations, dated January 17, 2011, concerning our investigator’s observations noted on the Form FDA 483, List of Inspectional Observations, which was issued at the conclusion of the inspection. We address this response below, in relation to each of the noted violations. These violations include, but are not limited to, the following:
1. Failure to establish and maintain procedures for implementing corrective and preventive actions, as required by 21 CFR 820.100(a). Specifically, there were no written procedures for analyzing, investigating, and identifying actions needed to correct quality problems such as those documented in Returned Merchandise Authorization (RMA) forms.
For example, two RMAs from different customers, both identified as 101607DN, reported that batteries incorrectly had female connectors when the design called for male connectors. These RMAs and their respective investigations were not documented or controlled through an established CAPA procedure. There was no evidence to demonstrate that these two RMAs were monitored for CAPA inclusion.
We reviewed your response and conclude that it is not adequate. Your firm stated that it has these procedures, but they are not listed in procedural protocol books. Your firm stated that it is in the process of implementing written procedures, but did not provide the procedures for review. In addition, your firm has not documented corrective actions to include consideration of any systemic corrective actions to address this observation.
2. Failure to establish and maintain procedures for receiving, reviewing, and evaluating complaints by a formally designated unit, as required by 21 CFR 820.198(a).
For example, your firm has not developed written procedures for receiving, reviewing, and evaluating complaints. Your firm uses RMA forms to document complaints, but the forms fail to document unique identification codes (e.g., lot numbers), investigations, and whether or not complaints were evaluated for reportability under the Medical Device Reporting Regulation (21 CFR 803).
We reviewed your response and conclude that it is not adequate. Your firm stated that it has these procedures, but they are not listed in procedural protocol books. Your firm stated that it is in the process of implementing written procedures, but did not provide the procedures for review. In addition, your firm has not documented corrective actions to include consideration of any systemic corrective actions to address this observation.
3. Failure to investigate complaints involving the possible failure of a device to meet any of its specifications, as required by 21 CFR 820.198(c).
For example, 21 out of 29 RMAs reviewed did not document an investigation into complaints that involved batteries failing to meet specifications. Specifically, the following RMAs did not document the date of investigation if one was performed, the results of the investigation, any product identification numbers, or any corrective action taken:
A. RMA #052207JA2 – Complainant stated that the (b)(4) Monitor Defibrillator “battery started on fire” in the “Why Returning” field in the RMA log.
B. RMA #072407JA – Complainant stated that six (b)(4) Monitor Defibrillator batteries were overheating.
C. RMA #120307JA – Complainant stated that the (b)(4) Monitor Defibrillator battery failed.
D. RMA #052610DN – Complainant stated that the (b)(4) Monitor Defibrillator battery failed.
E. RMA #111207JA – Complainant stated that the (b)(4) Monitor Defibrillator battery was bad.
We reviewed your response and conclude that it is not adequate. Your firm stated that it is presently implementing procedures to properly document all investigations, product identification numbers (lot codes), and all corrective actions. Your firm further stated that it is developing a procedure book. However, the new procedures, documentation of investigations, and corrective actions were not provided for review. In addition, your firm has not documented corrective actions to include consideration of any systemic corrective actions to address this observation.
4. Failure to establish and maintain procedures to ensure that all purchased or otherwise received product and services conform to specified requirements, as required by 21 CFR 820.50.
For example, your firm does not have written procedures defining the requirements that must be met by its suppliers. Additionally, there was no documentation that suppliers had been evaluated and selected based on their ability to meet specified requirements.
We reviewed your response and conclude that it is not adequate. Your firm stated that it has these procedures, but they are not listed in procedural protocol books. Your firm is in the process of implementing written procedures, but did not provide the procedures for review. In addition, your firm has not documented corrective actions to include consideration of any systemic corrective actions to address this observation.
5. Failure to establish and maintain procedures for finished device acceptance to ensure that each production run, lot, or batch of finished devices meets acceptance criteria, as required by 21 CFR 820.80(d). Specifically, your firm does not have written procedures that define acceptance criteria and ensure that devices are not released for distribution until required acceptance activities are completed and the release is authorized by the signature of a designated individual.
For example:
A. 23 – (b)(4) Anesthesia Machine Batteries) were released on 9/28/07. Two batteries were returned through RMA #101607DN due to the battery being built with female pins where the design called for male pins. This was not identified during final acceptance testing, documented, or captured in the Design History Record (Pick Ticket #2130).
B. Eight –(b)(4) Anesthesia Machine Batteries) were released on 10/1/07. Eight were returned through RMA #101607DN due to the battery being built with female pins when the design called for male pins. This was not identified during final acceptance testing, documented, or captured in the Design History Record (Pick Ticket #2154).
We reviewed your response and conclude that it is not adequate. Your firm stated that it has these procedures, but they are not listed in procedural protocol books. Your firm is in the process of implementing written procedures, but did not provide the procedures for review. In addition, your firm has not documented corrective actions to include consideration of any systemic corrective actions to address this observation.
6. Failure to establish and maintain procedures for acceptance of incoming product, as required by 21 CFR 820.80(b).
For example, your firm did not have an established procedure for the acceptance of incoming product, and there was no documentation or reference to acceptance activities for materials used in production. Specifically, RMA #0101908DN was opened as a result of 75 out of (b)(4) of the (b)(4) Sealed Lead Batteries being returned as “bad.” This is a “pass-thru” battery, and there was no documentation of acceptance activities for this product when it was received by your firm.
We reviewed your response and conclude that it is not adequate. Your firm stated that all incoming products are inspected for compliance with specified requirements at all times. However, your firm did not provide any documentation to demonstrate that all incoming products are inspected to ensure specified requirements are met. Furthermore, your firm stated you are currently implementing procedures for acceptance, a book for documentation, and testing requirements. The new procedures for acceptance, testing requirements, and documentation of testing have not been provided for review. In addition, your firm has not documented corrective actions to include consideration of any systemic corrective actions to address this observation.
7. Failure to establish and maintain procedures to control product that does not conform to specified requirements, as required by 21 CFR 820.90.
For example, when a product or component fails to meet specifications, there is no procedure to instruct employees how to handle the non-conforming product or component. Furthermore, there is no documentation of the failure or disposition of the product or component.
We reviewed your response and conclude that it is not adequate. Your firm stated that it has these procedures, but they are not listed in procedural protocol books. Your firm is in the process of implementing written procedures, but did not provide the procedures for review. In addition, your firm has not documented corrective actions to include consideration of any systemic corrective actions to address this observation.
8. Failure to establish and maintain procedures to ensure that Device History Records (DHRs) for each batch, lot, or unit are maintained to demonstrate that devices were manufactured in accordance with the Device Master Record (DMR), as required by 21 CFR 820.184.
For example, 44 battery DHRs were reviewed and found that:
A. 44 of 44 did not document or reference the finished devices’ identification or control number (manufacturer assigned lot number).
B. 38 of 44 did not document or reference labels, where appropriate, used for each finished product, lot, or batch. Additionally, the DHRs did not include records of examination and release of device labeling, including the date and signature of the examiner.
C. 31 of 44 did not document or reference final acceptance activities including (b)(4) testing for all released finished devices. For example, your firm conducts (b)(4) testing for assembled battery packs, but it only lists (b)(4) test result. Furthermore, it does not document the date these activities were performed.
D. 20 of 44 did not document the assembler that signed off on manufacturing or re-labeling of the finished device.
We reviewed your response and conclude that it is not adequate. Your firm stated that it has implemented new and specific procedures, documentation, and labeling to conform to the FDA requirements per 21 CFR 820. Your firm further stated that the correction was completed on 1/13/11. However, the new procedures, documentation, or labeling for the correction have not been provided for review. In addition, your firm has not documented corrective actions to include consideration of any systemic corrective actions to address this observation.
9. Failure to maintain an adequate Device Master Record (DMR), as required by 21 CFR 820.181.
For example, the S1025RF/CN specification drawing for the (b)(4) defibrillator fails to identify or reference the (b)(4) used in manufacturing. It also does not document acceptance criteria and a formal production method/procedure for the manufacturing and labeling of the device. In addition, the S1025RF/CN design drawing/specification sheet does not document management’s approval or the date the data sheet and drawing were approved.
We reviewed your response and conclude that it is not adequate. Your firm stated that it has adequately maintained device master record books, but that the investigator never asked to see them. Your firm also stated that it is currently implementing the proper changes to drawings in sample boxes. Your firm is also currently approving device records of these drawings and properly dating the approvals. Your response, however, did not address the lack of method/procedures and acceptance criteria in master record books for the devices. In addition, no device master record information was provided for review and your firm has not documented corrective actions to include consideration of any systemic corrective actions to address this observation.
10. Failure to establish procedures for management review of the quality system and documentation of the dates and results of quality system reviews, as required by 21 CFR 820.20(c).
For example, your firm has not established procedures for conducting management reviews. Your firm stated that the management team will hold meetings, when necessary, and the last management review was conducted in June 2010. However, the dates and results of these meetings are not documented.
We reviewed your response and conclude that it is not adequate. Your firm stated that it has these procedures, but they are not listed in procedural protocol books. Your firm is in the process of implementing written procedures, but did not provide the procedures for review. In addition, your firm has not documented corrective actions to include consideration of any systemic corrective actions to address this observation.
11. Failure to establish procedures for quality audits and to conduct such audits to assure that the quality system is in compliance with the established quality system requirements, as required by 21 CFR 820.22.
For example, your firm has not established procedures for conducting quality audits. Your firm stated that it conducts quality audits and that the last quality audit was completed in June 2010. However, your firm has not documented the dates and results of these audits.
We reviewed your response and conclude that it is not adequate. Your firm stated that it has these procedures, but they are not listed in procedural protocol books. Your firm is in the process of implementing written procedures, but did not provide the procedures for review. In addition, your firm has not documented corrective actions to include consideration of any systemic corrective actions to address this observation.
Our inspection also revealed that your devices are misbranded under section 502(t)(2) of the Act, 21 U.S.C. § 352(t)(2), in that your firm failed or refused to furnish material or information respecting the device that is required by or under section 519 of the Act, 21 U.S.C. § 360i, and 21 CFR 803 - Medical Device Reporting (MDR) regulation. Significant violations include, but are not limited to, the following:
Failure to develop, maintain, and implement written MDR procedures, as required by 21 CFR 803.17.
For example, the investigator requested written procedures related to complaints or completing the RMA forms. Your firm did not establish a procedure to review complaints or evaluate them for MDR reportability. Specifically, the RMA log for RMA #052207JA2 stated that a NCE part number (b)(4) Monitor-Defibrillator) battery “started on fire.” Any evaluation for MDR reportability was not documented. Further, there was no documentation of an investigation into this complaint.
We reviewed your response and conclude that it is not adequate. Your firm has not provided for review the completed MDR procedure reporting book referenced in your response.
Under section 510 of the Act, 21 U.S.C. § 360, manufacturers of medical devices are required to annually register with the FDA. In September 2007, section 510 of the Act was amended by the Food and Drug Administration Amendments Act of 2007 (Pub. L. 110-85) to require domestic and foreign device establishments to submit their annual establishment registration and device listing information to FDA by electronic means, section 510(p) of the Act, 21 U.S.C. § 360(p), during the period beginning October 1st and ending December 31st of each year. Our records indicate that you have not fulfilled your annual listing requirements for fiscal year 2011.
Therefore, your replacement batteries are also misbranded within the meaning of section 502(o) of the Act, 21 U.S.C. § 352(o), in that the devices were not included in a list required by section 510(j), 21 U.S.C. § 360(j). Currently, you have submitted only one device listing (Oximeter, 21 CFR 870.2700), but your firm re-labels replacement batteries for numerous other devices. Information about device listing can be found on the Internet at http://www.fda.gov/MedicalDevices/
DeviceRegulationandGuidance/HowtoMarketYourDevice/RegistrationandListing/default.htm.
Your firm should take prompt action to correct the violations addressed in this letter. Failure to promptly correct these violations may result in regulatory action being initiated by the Food and Drug Administration without further notice. These actions include, but are not limited to, seizure, injunction, and/or civil money penalties. lso, federal agencies are advised of the issuance of all Warning Letters about devices so that they may take this information into account when considering the award of contracts. Additionally, premarket approval applications for Class III devices to which the Quality System regulation violations are reasonably related will not be approved until the violations have been corrected. Requests for Certificates to Foreign Governments will not be granted until the violations related to the subject devices have been corrected.
Please notify this office in writing within 15 business days from the date you receive this letter of the specific steps your firm has taken to correct the noted violations, as well as an explanation of how your firm plans to prevent these violations, or similar violations, from occurring again. Include documentation of the corrections and/or corrective actions your firm has taken. If the planned corrections and/or corrective actions will occur over time, please include a timetable for implementation of these activities. If corrections and/or corrective actions cannot be completed within 15 business days, state the reason for the delay and the time within which these activities will be completed. Your firm’s response should be comprehensive and address all violations included in this Warning Letter.
Your firm’s response should be sent to Timothy G. Philips, Compliance Officer, at the address on this letterhead. If you have any questions about the content of this letter, please contact Mr. Philips at (612) 758-7133.
Finally, you should know that this letter is not intended to be an all-inclusive list of the violations at your facility. It is your responsibility to ensure compliance with applicable laws and regulations administered by FDA. The specific violations noted in this letter and in the Inspectional Observations, Form FDA 483, issued at the close-out of the inspection may be symptomatic of serious problems in your firm’s manufacturing and quality management systems. You should investigate and determine the causes of the violations and take prompt actions to correct them and to bring your firm’s products into compliance.
Sincerely,
/s/
Gerald J. Berg
Director
Minneapolis District
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