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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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GYN Disposables, Inc. 8/15/11


Department of Health and Human Services logoDepartment of Health and Human Services

Public Health Service
Food and Drug Administration
 New Orleans District
404 BNA Drive
Building 200 - Suite 500
Nashville, TN 37217
Telephone: (615) 366-7801
FAX: (615) 366-7802 


August 15, 2011
James K. Patterson, M.D., CEO
GYN Disposables, Inc.
3150 Stage Post Drive, Suite 103
Memphis, Tennessee 38133-4050
Dear Dr. Patterson:
During an inspection of your firm, located in Memphis, Tennessee, on April 5, 2011, through April 12, 2011, an investigator from the United States Food and Drug Administration (FDA) determined your firm manufactures IUD Insertion Kits and Endometrial Biopsy Kits. Under Section 201(h) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 United States Code (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 these devices are adulterated within the meaning of Section 501(h) of the Act [21 U.S.C. § 351(h)], because 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, Part 820 (21 CFR 820). 
We received responses from your firm dated April 28, June 16, and July 15 of 2011, concerning our investigator’s observations noted on the Form FDA 483 (FDA 483), Inspectional Observations, issued to your firm. We address these responses below, in relation to each of the noted violations. These violations include, but are not limited to, the following:
1. Failure to ensure when the results of a process cannot be fully verified by subsequent inspection and test, the process shall be validated with a high degree of assurance and approved according to established procedures, as required by 21 CFR 820.75(a). For example, your firm lacks documentation to demonstrate the package and seal integrity final acceptance test method has been validated. In addition, your firm lacks validation data for the sterilization and packaging process for all lots of the sterile single-use IUD Insertion Kit and Endometrial Biopsy Kit.
Your responses dated April 28, and June 16, 2011, are not adequate. You confirmed your firm’s contract manufacturer is responsible for performing the final acceptance and release activities for the seals based on input from the firm. However, your response failed to include records of validation studies and testing data for seal integrity to assure the contract manufacturer is adequately validating the relevant process and complying with your firm’s acceptance requirements.  
2. Failure to establish and maintain 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 lacks documentation of the type and extent of control to be implemented in order to ensure the contract manufacturer has established and maintains procedures for monitoring and controlling the process parameters for processes that require validation, such as (b)(4) sterilization and the package sealing process. 
Your responses dated April 28, and June 16, 2011 are not adequate. You have recognized procedures need to be in place for monitoring and control of the processes and the contract manufacturer needs to be aware of these requirements. You promised to have these procedures and training of all affected employee completed by June 17, 2011. However, no such procedures and training records are submitted for review. You updated the Certificate of Compliance to include requirements for documenting sterility status (pass/fail) and method (b)(4). This certificate alone is insufficient to determine the validity of the sterilization process. You intended to incorporate the monitoring/process parameter requirements in the Supplier Evaluation procedure (SOP 7.4.1). The Evaluation Procedure (SOP 7.4.1) lacks instructions for how the sterilization process will be monitored and what parameters will be controlled. You also intended to conduct an annual audit no later than August 2011, to cover detail reviews of the process data, sterilization and packaging validation activities, and monitoring. However, you have not established a procedure to conduct this audit. 
3. Failure to establish and maintain adequate procedures for acceptance activities, as required by 21 CFR 820.80(a). For example, 8.2.4-SOP, Monitoring and Measurement of Product, does not provide specific instructions on how to perform the acceptance activities required for product release including acceptance criteria, test method, and equipment used.
Your responses dated April 28, and June 16, 2011, are not adequate. Your updated procedure, 8.2.4-SOP, Monitoring and Measurement of Product fails to address the above-identified issues. 
4. Failure to establish and maintain adequate procedures for verifying or validating the corrective and preventive action to ensure such action is effective and does not adversely affect the finished device, as required by 21 CFR 820.100(a)(4). For example, your CAPA report #2005, dated August 3, 2009, indicates the contract manufacturer does not provide process data related to product sterilization. Your corrective actions include: (1) an immediate action to reiterate the data be available for review from the contract manufacturer; (2) a long term corrective action to specifically review for this issue during the next audit of the contract manufacturer; and, (3) an action taken to specify a microbiology item be included in the next contract manufacturer audit. However, no audit has been conducted and no other action has been taken to address this issue since 2008. You continued to release your product based on the Certificate of Compliance (CPAR #0026), which fails to assure the sterilization process has been validated.      
Your responses dated April 28, 2011, June 16, 2011, and July 15, 2011, are not adequate. Your responses failed to provide data supporting the above‑identified issues. Your updated CAPA procedure, 8.5-SOP-Improvement/CAPA, fails to address the requirements set forth in 21 CFR 820.100(a)(1-7). Your responses failed to address a retrospective review of all CAPAs will be done per the revised procedure.  
5. Failure to review, evaluate, and investigate complaints involving the possible failure of a device, labeling, or packaging to meet any of its specifications unless such investigation has already been performed for a similar complaint and another investigation is not necessary, as required by 21 CFR 820.198(c). For example, your Customer/Distributors/Representative/ Employee Suggestions and Feedback form revealed several device failures, such as tenaculum being too sharp, tenaculum causing trauma and bleeding, and tenaculum failing to hold and/or lock (2011 Suggestion and Feedback form item numbers 1, 2, 11, 12, 14, 17, 18, and 21). You failed to handle these failures as complaints per your firm’s procedure 8.2.1-SOP, Feedback.
Your responses dated April 28, 2011, and June 16, 2011, are not adequate. To address the above issue, you have updated the Complaint Handling Procedure, logged complaints into a complaint system, and planned to investigate complaints per the updated procedure. You also planned to review customer feedback from 2010-2011 to determine whether any of the feedback information needs to be logged/categorized as complaints and thus would require investigation. However, your response failed to address a retrospective review of all complaints will be done to determine if historical complaints need to be reviewed in the same manner. Your response additionally failed to provide evidence of implementation of your planned actions.
6. Failure to establish and maintain adequate procedures for validating the device design, as required by 21 CFR 820.30(g). For example, your procedure, 7.3-SOP, Design and Development, and corresponding forms failed to provide instructions for how and when design validation will be performed. 
Your responses dated April 28, 2011, and June 16, 2011, are not adequate. You planned to update necessary procedures and forms to include the validation requirements. You have indicated your validation process for the IUD Insertion Kit will be reviewed and updated to meet the new requirements. These planned actions are expected to be completed by August 31, 2011. However, you failed to assure other devices (i.e., endometrial biopsy kits) distributed by your firm would also be addressed in the similar manner.
Our inspection also revealed your IUD Insertion Kit is adulterated under Section 501(f)(1)(B) of the Act, 21 U.S.C. 351(f)(1)(B), because your firm does not have an approved application for premarket approval (PMA) in effect pursuant to Section 515(a) of the Act, 21 U.S.C. 360e(a), or an approved application for an investigational device exemption (IDE) under Section 520(g) of the Act, 21 U.S.C. 360j(g).  The device is also misbranded under Section 502(o) the Act, 21 U.S.C. 352(o), because your firm did not notify the agency of its intent to introduce the device into commercial distribution, as required by Section 510(k) of the Act, 21 U.S.C. 360(k).  For a device requiring premarket approval, the notification required by Section 510(k) is deemed satisfied when a PMA is pending before the agency [21 CFR 807.81(b)].  The kind of information your firm needs to submit in order to obtain approval or clearance for the device is described on FDA’s Internet website at http://www.fda.gov/cdrh/devadvice/3122.html. The FDA will evaluate the information your firm submits and decide whether the product may be legally marketed.
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 FDA without further notice.  These actions include, but are not limited to, seizure, injunction, and civil money penalties.  Federal agencies may be advised of the issuance of warning letters about devices so 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 fifteen (15) business days from the date you receive this letter of the specific steps your firm has taken to correct the noted violations, including an explanation of how you plan to prevent these violations, or similar violations, from recurring again.  Include documentation of the corrective actions (including any systemic corrective actions) you have taken.  If your planned corrective actions will occur over time, please include a timetable for implementation of those corrections.  If 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 response should be comprehensive and address all violations included in this warning letter.
Your response should be sent to: Kari L. Batey, Compliance Officer, at the address above. If you have any questions about the content of this letter, please contact: Ms. Batey at (615) 366-7808.
Finally, you should know 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 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 bring the products into compliance. 



Thomas D. Clarida
Acting District Director
New Orleans District Office