| Public Health Service Food and Drug Administration |
Minneapolis District Office |
Department of Health and Human ServicesJuly 14, 2011
WARNING LETTER
CERTIFIED MAIL
RETURN RECEIPT REQUESTED
Refer to MIN 11 - 38
C. Kent Gawart
Chief Operating Officer
Nemschoff Chairs, Inc.
909 North Eighth Street
Sheboygan, Wisconsin 53081-4056
Dear Mr. Gawart:
During an inspection of your firm located in Sheboygan, Wisconsin, on May 3-4, 2011, an investigator from the Food and Drug Administration (FDA) determined that your firm manufactures bassinets. 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 (21 CFR), Part 820.
We received a response from you dated May 24, 2011, concerning our investigator’s observations noted on the form FDA-483, List of Inspectional Observations, that was issued to you. 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 to control the design of the device in order to ensure that specified design requirements are met, as required by 21 CFR 820.30(a). For example, your firm has not developed a design control procedure that meets minimal requirements, including a design plan and requirements for design inputs to equal outputs and directed at the device’s intended use.
We reviewed your response and conclude that it is not adequate. You stated in your response that within 60 days your firm will implement a Design Control process procedure. However, there was no mention of a systemic corrective action that includes retrospective review of bassinets to ensure that the design controls are adequate. Additionally, your firm did not provide a copy of the procedure for review and did not explain its implementation plan, to include the training of personnel performing these tasks.
2. Failure to establish and maintain procedures for implementing corrective and preventive action, as required by 21 CFR 820.100(a). For example, your firm has no CAPA procedures.
We reviewed your response and conclude that it is not adequate. You stated in your response that within 30 days your firm will establish a CAPA process and procedure. However, there was no mention of retrospective review to ensure that potential causes of nonconforming products will be addressed under CAPA. Additionally, your firm did not provide a copy of the procedure for review and did not explain its implementation plan, to include the training of personnel performing these tasks.
3. 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, there is no formal documented procedure for reviewing and evaluating the complaints to ensure they are processed in a timely manner, documented upon receipt, or evaluated for medical device reporting.
We reviewed your response and conclude that it is not adequate. You stated in your response that within 30 days your firm will implement a Complaint Management system that includes a Medical Device Reporting procedure. However, there was no mention of systemic corrective action that includes a retrospective review of all complaints to determine whether complaints have been adequately received, reviewed, and evaluated to determine whether an investigation was necessary. Additionally, your firm did not provide a copy of the procedure for review and did not explain its implementation plan, to include the training of personnel performing these tasks.
4. Failure to develop, conduct, control, and monitor production processes to ensure that a device conforms to its specifications, as required by 21 CFR 820.70(a). For example, your firm has no procedures for developing, conducting, controlling, and monitoring production processes to ensure that your bassinets conform to your specifications.
We reviewed your response and conclude that it is not adequate. You stated in your response that within 60 days your firm will provide to FDA the remaining sub-systems of the compliant Quality System. However, your firm did not provide a preliminary systemic corrective action plan or explain its implementation plan.
Our inspection also revealed that your bassinet 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 regarding the device that is required by or under section 519 of the Act, 21 U.S.C. § 360i, and 21 CFR Part 803 – Medical Device Reporting (MFR) regulation. Significant violations include, but are not limited to, the following:
5. Failure to develop, maintain, and implement written Medical Device Reporting (MDR) procedures, as required by 21 CFR 803.17. For example, your firm has no written MDR procedures.
We reviewed your response and conclude that it is not adequate. You stated in your response that within 30 days your firm will implement a Complaint Management system that includes a Medical Device Reporting procedure. However, there was no mention of systemic corrective action that includes a retrospective review of all complaints to determine whether any complaint represented an event that must be reported under 21 CFR Part 803 – Medical Device Reporting.
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 registration and listing requirements for fiscal year 2011.
Therefore, all of your devices are misbranded within the meaning of section 502(o) of the Act, 21 U.S.C. § 352(o), in that the devices were manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510, 21 U.S.C. § 360, and were not included in a list required by section 510(j), 21 U.S.C. § 360(j).
A follow-up inspection will be required to assure that corrections and/or corrective actions are adequate.
You 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. Also, 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 you have taken to correct the noted violations, as well as an explanation of how you plan to prevent these violations, or similar violations, from occurring again. Include documentation of the corrections and/or corrective actions you have taken. If your 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 response should be comprehensive and address all violations included in this Warning Letter.
Your response should be sent to Melissa I. Michurski, Compliance Officer, at the address on the letterhead. If you have any questions about the content of this letter please contact Ms. Michurski at (612) 758-7185.
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 the violations and to bring your products into compliance.
Sincerely,
/s/
Gerald J. Berg
Director
Minneapolis District
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