| Public Health Service Food and Drug Administration |
Florida District |
Department of Health and Human ServicesCERTIFIED MAIL
RETURN RECEIPT REQUESTED
WARNING LETTER
FLA-12-05
November 1, 2011
Mr. Ilhan M. Bilgutay
Pace Tech, Inc.
510 North Garden Avenue
Clearwater, Florida 33755-4126
Dear Mr. Bilgutay:
During an inspection of your firm located in Clearwater, FL, on July 7, 2011, through July 13, 2011, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures Vitalmax 4000 Patient Monitoring Device. Under section 201(h) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. § 321(h), this product is a device because it is intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease, or is intended to affect the structure or function of the body.
This inspection revealed that this device is 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 requirements of the Quality System (QS) regulation found at Title 21, Code of Federal Regulations (CFR), Part 820. We received a response from Mr. Stamatios F. Parimeros, General Manager, dated August 1, 2011, concerning our investigator’s observations noted on the Form FDA 483 (FDA 483), List of Inspectional Observations that was issued to your firm. 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 adequate procedures for implementing corrective and preventive action, as required by 21 CFR 820.100(a).
For example:
a. According to the section 1.2 of your firm’s Corrective and Preventive Action Procedure, QOP 85-04, Rev. 07, quality assurance is responsible for reviewing various quality related data and initiating a preventive action. It further states that such data items will be analyzed on a monthly basis. However, your firm did not conduct reviews of quality related data between 2008 and April 2011.
b. Your firm’s Corrective and Preventive Action Procedure, QOP 85-04, Rev. 07, does not specify that actions needed to correct and prevent recurrence of nonconforming product and other quality problems must be verified and/or validated to ensure that such actions are effective and do not adversely affect the finished device.
c. According to the section 4.1.2 of your firm’s Corrective and Preventive Action Procedure, QOP 85-04, Rev. 07, results of the investigation shall be documented on the Root Cause Investigation form F8504-3. However, CAPA report 2011-004 dated April 6, 2011, and report 2011-010 dated May 26, 2011, did not have the investigation documented on the Root Cause Investigation form F8504-3.
We have reviewed your firm’s response and conclude that it is not adequate. Your firm’s response does not indicate whether your firm conducted a review of quality related data per procedure QOP 85-04, Rev. 7. Your firm provided a revised Corrective and Preventive Action Procedure, QOP 85-04, Rev. 08, which states that corrective action should be verified and/or validated before CAPA is closed out, and that all personnel have been trained on revised procedure. However, your firm did not provide any training records indicating the training had been completed. In addition, your firm did not indicate that a systemic corrective action, in terms of retrospective review of the CAPAs to determine whether or not verification and/or validation activities should be performed for the implemented corrections and/or corrective actions, was considered. Your firm’s response also indicated that, for CAPA report 2011-004, an investigation was documented using the complaint investigation form #F7203-2B. Your firm also states that several other CARs did not use stated root cause investigation form. However, your firm neither provided the referenced complaint investigation form nor indicated a plan regarding CARs where the root cause investigation form was not completed.
2. Failure to establish and maintain adequate requirements, including quality requirements, that must be met by suppliers, contractors, and consultants, as required by 21 CFR 820.50(a).
For example, your firm uses supplier evaluation form, F-7401-2A, for initial and continuous evaluation of a supplier. Such evaluations are based on a scoring mechanism that determines whether the supplier is acceptable. However, a supplier could receive an overall acceptable score while receiving a score of zero in the quality category.
We have reviewed your firm’s response and conclude that it is not adequate. In the response your firm indicated that it has revised the supplier evaluation form and provided new version F-7401-2B. In the new version, a supplier will not receive an acceptable score if they fail to meet the minimum requirements in each category. However, your firm did not indicate that all necessary employees were trained on using the new form. Your firm also did not provide documentation that a systemic corrective action was considered, in terms of evaluation of existing supplier using new form, to ensure that existing suppliers met minimum quality requirements.
3. Failure to establish and maintain adequate procedures that define the responsibility for review and authority for the disposition of nonconforming product, as required by 21 CFR 820.90(b)(1).
For example, according to section 3.2 of your firm’s Control of Nonconforming Product procedure, QOP 83-01, Rev. 02, the QC inspector and production supervisor are authorized to decide jointly when product must be scrapped and that both signatures are required on the respective nonconformance report. However, nonconformance report NC11-001, dated April 6, 2011, indicates that a (b)(4) LCD display was scrapped due to wavy lines on the screen without any documented signatures.
We have reviewed your firm’s response and conclude that it is not adequate. In the response your firm provided a revised Control of Nonconforming Product Procedure, QOP 83-01, Rev. 03, which states that quality manager will be responsible for determination regarding the disposition of nonconforming product and the associated signature. Additionally, your firm stated that all personnel have been trained on the revised procedure. However, your firm did not provide any training records indicating the training had been completed. Your firm did not provide documentation that a systemic corrective action was considered, in terms of review of all nonconformance reports related to product disposition, to determine appropriateness of the documentation.
4. Failure to ensure that all inspection, measuring, and test equipment is routinely calibrated, as required by 21 CFR 820.72(a).
For example, your firm has no records to demonstrate calibration was performed between 2009 and 2011 for the multimeters, Electrostatic discharge equipment, and equipment used for final testing of the Vitalmax 4000 device.
We have reviewed your firm’s response and conclude that it is not adequate. In the response your firm indicated that all final test equipment were sent for calibration and provided calibration records for SpO2 Simulator, Medtester, Pressure Analyzer, and Patient Simulator. However, your firm did not provide documentation that a systemic corrective action was considered to ensure that all required inspection, measuring, and test equipment were checked and sent for calibration.
5. Failure to maintain Device History Records (DHR’s) for each batch, lot, or unit to demonstrate that the device is manufactured in accordance with the Device Master Record (DMR) and the requirements of 21 CFR Part 820, as required by 21 CFR 820.184.
For example, DHR’s for the devices produced between February 1, 2011, and May 11, 2011, only included final testing documentation.
We have reviewed your firm’s response and conclude that it is not adequate. In the response, your firm provided a revised Final Inspection Procedure, QOP 82-05, Rev. 03, indicating what documents are required for DHR and how they should be stored. However, the procedure does not clarify who is responsible for this task and how the DHR will be reviewed for its completeness before filing. Your firm also did not provide documentation that a systemic corrective action was considered to ensure all other DHR’s were reviewed for their completeness.
6. Failure to maintain an adequate Device Master Record, as required by 21 CFR 820.181.
For example, the Device Master Record did not include or reference the location of label specifications for the Vitalmax 4000 device.
We have reviewed your firm’s response and conclude that it is not adequate. In the response, your firm indicated that the DMR has been updated to include or reference the location of label specifications. However, your firm did not provide documentation that a systemic corrective action was considered to ensure that the other required information related to the DMR was accurate.
7. Failure to establish an adequate management review procedure to ensure that the quality system satisfies the requirements of 21 CFR Part 820 and the manufacturer's established quality policy and objectives, as required by 21 CFR 820.20(c).
For example:
a. According to the section 1.1 of your firm’s management review procedure, QOP 56-01, Rev. 01, quality performance and the quality management systems are reviewed by the executive management at least once a year. However, your firm did not conduct any management reviews during the years 2008, 2009, and 2010.
b. According to the section 2.1 of your firm’s management review procedure, QOP 56-01, Rev. 01, management review meetings are chaired by the President and are attended by the heads of the Quality Assurance, Engineering, Production, Purchasing, Customer Service, and Regulatory Affairs department. However, Management Meeting Agenda, F-5601-1A, dated April 19, 2011, lists attendees as General Manager, Quality Manager, and Engineering Head.
We have reviewed your firm’s response and conclude that it is not adequate. In the response, your firm indicated that the company’s management structure has changed and that the president has delegated day-to-day operation responsibility to the general manger. Your firm provided the revised management review SOP, QOP 56-01, Rev. 02, which reflects that management review meetings will be chaired by the general manager; and will be attended by the quality manager and chief engineer. However, your firm did not provide documentation that a systemic corrective action was considered that involved revision of all documents, which reference the president, to reflect this change in responsibility.
Our inspection also revealed that your firm’s device is 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 Part 803 - Medical Device Reporting. Significant deviations include, but are not limited to, the following:
Failure to develop, maintain and implement written MDR procedures as required by 21 CFR 803.17.
1. Your firm’s procedure fails to establish internal systems that provide for a standardized review process or procedure for determining when an event meets the criteria for reporting to FDA, including:
a. The procedure does not define what your firm will consider to be a reportable event. To facilitate the correct interpretation of reportable events and to assure the quality of MDR submissions, the procedure should include definitions based on 21 CFR Part 803.3 for:
i. Become aware: for example, when the phrase “become aware” is used in the procedure it should include “from any source”;
ii. Caused or contributed;
iii. Malfunction: the definition should be revised to remove … “objective intent of the person legally responsible for the labeling of the device”;
iv. MDR reportable event;
v. Serious injury: the definition should be revised to remove the phrase “by a health professional” ; and
vi. Definitions for reasonably known found in Part 803.50(b), and reasonably suggests found in Part 803.20(c)(1).
b. Section 5.d. of your firm’s procedure, which refers to when an MDR is not required, is incorrect and may lead to failure to report. For example, information given in the device’s labeling does not preclude a manufacturer from submitting an MDR when the event meets the threshold for reportability. Refer to 21 CFR Part 803.22.
c. Your firm’s procedure fails to describe a process for conducting a complete investigation of each event to determine the cause of an event.
2. Your firm’s procedure fails to provide instructions for the timely submission of complete medical device reports including:
a. How to submit the mandatory report form “FDA Form 3500A,” not Form 3500 used for voluntary reporting;
b. The types of information to be included on the FDA Form 3500A; Section 5.c. omits several requirements from Part 803.52 including portions of (a) patient information; (b) adverse event or product problem; (c) device information; (d) initial reporter; (e) reporting information for all manufacturers; and (f) device manufacturer information;
c. All circumstances under which an event must be submitted as a 5-day report, for example, if requested by FDA;
d. How your firm will submit all information reasonably known to it;
e. The circumstances under which your firm must submit a supplemental or follow-up report and the requirements for such reports; and
f. How to submit reports for events that occur outside the U.S. If an event involves a device that is the same or similar to a device with marketing approval in the U. S., then the firm must also evaluate these events for reportability and submit MDRs as required.
3. Your firm’s procedure fails to describe how it will address documentation and record-keeping requirements including:
a. Documentation of adverse event related information maintained as MDR event files;
b. Documentation of the deliberations and decision-making processes used to determine if a device-related death, serious injury, or malfunction was or was not reportable; and
c. A process to permit any authorized FDA employee to access records.
4. Your firm’s procedure combines language from requirements of other regulatory or competent authorities with those from Part 803. This may cause confusion leading to incomplete, inadequate or even non-reporting of adverse events that meet the reportability requirements under Part 803.
We have reviewed your firm’s response and conclude that it is not adequate. The revised Medical Device Reporting Procedure, QOP-72-04, Rev. 04, Effective July 29, 2011, included in your firm’s response is not adequate as it does not address the deficiencies listed above.
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. Also, federal agencies may be advised of the issuance of 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 QS regulation deviations 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.
We are requesting that your firm submit to this office on the schedule below, certification by an outside expert consultant that he/she has conducted an audit of your establishment's manufacturing and quality management systems relative to the requirements of the device QS regulation (21 CFR Part 820). Your firm should also submit a copy of the consultant's report, and certification from yourself that you have reviewed the consultant's report and that your establishment has initiated or completed all corrections called for in the report. The initial certifications of audit and corrections and subsequent certifications of updated audits and corrections (if required) should be submitted to this office by the following dates:
• Initial certifications by consultant and establishment – May 1, 2012.
• Subsequent certifications – December 1, 2012.
Please notify this office in writing within fifteen 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 (including any systemic corrective actions) that your firm has taken. If your firm’s planned corrections and/or corrective actions (including any systemic corrective actions) will occur over time, please include a timetable for implementation of those activities. If corrections and/or corrective actions (including any systemic corrective actions) cannot be completed within fifteen 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: Ms. Andrea Norwood, Compliance Officer, Florida District Office, 555 Winderley Place, Suite 200, Maitland, Florida 32751. Refer to CMS Case # 213474 when replying. If your firm has any questions about the contents of this letter please contact: Ms. Norwood via telephone at (407) 475-4700 or via fax at (407) 475-4769.
Finally, your firm should know that this letter is not intended to be an all-inclusive list of the violations at your firm’s facility. It is your firm’s responsibility to ensure compliance with applicable laws and regulations administered by FDA. The specific violations noted in this letter and in the Inspectional Observations, FDA 483, issued at the close of the inspection may be symptomatic of serious problems in your firm’s manufacturing and quality management systems. Your firm should investigate and determine the causes of the violations, and take prompt actions to correct the violations and to bring the products into compliance.
Sincerely,
/s/
Emma R. Singleton
Director, Florida District
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