Inspections, Compliance, Enforcement, and Criminal Investigations
Gaven Medical 6/26/09
Department of Health and Human Services
|Public Health Service
Food and Drug Administration
|New England District
One Montvale Avenue
Stoneham, Massachusetts 02180
FAX: (781) 596-7896
VIA CERTIFIED MAIL
June 26, 2009
Mr. Joseph V. Bak,
President / Manager
Gaven Medical, LLC.
129 Reservoir Road
Vernon, CT 06066-5705
Dear Mr. Bak:
During an inspection of your firm, Gaven Medical, LLC, 129 Reservoir Road, Vernon CT, on April 27 through May 8, 2009, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures medical devices, specifically sterile ”Punctur – Guard Winged Sets” for blood collection. 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 above 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) regulations found at Title 21, Code of Federal Regulations (C.F.R.), Part 820. These violations include, but are not limited to the following:
1. Failure to maintain a device history record (DHR) that includes acceptance records which demonstrate that the device is manufactured in accordance with the DMR (device master record), as required by 21 CFR § 820.184(d). For example, you received sterility processing records from your contract sterilizer, (b)(4) on September 19, 2008, for lot #J0581B of Punctur-Guard Winged Set, item #5312, that demonstrated the average surface dose received for this lot was (b)(4) Your Winged Set Sterilization Procedure does not reference an average surface dose as an appropriate specification. There is no documentation in your device history records that demonstrate your firm reviewed the sterility results prior to the distribution of this lot.
2. Failure to establish and maintain procedures that define the responsibility for review and authority of the disposition of non conforming product, which include the documentation of the disposition of the non conforming product, as required by 21 CFR § 820.90(b)(1). For example, on May 19, 2008, your contract sterilizer, (b)(4), rejected 2 cases of Punctur-Guard Winged Sets, item #5312, lot E0181B. Your firm did not have any documentation to demonstrate that these 2 non conforming cases were dispositioned properly and were not released for distribution.
3. Failure to establish and maintain procedures for implementing corrective and preventive actions, including requirements for investigating the cause of nonconformities relating to product, processes, and the quality system, as required by 21 CFR § 820.100(a)(2). For example, your firm failed to investigate the possible root causes for the rejection of 2 cases of medical devices by your contract sterilizer, as described above.
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 had at least three different specifications for one of your final release tests, the “3rd wing tubing pull test”. One document listed a specification of (b)(4)”, another as “(b)(4)”, another at “(b)(4)” and another as, (b)(4).”
Also, your firm does not have adequate specifications for peel strength tests which are conducted to assure that the package seal provides a sterile barrier. During the inspection, we observed that you stopped conducting burst tests and are only performing a visual inspection of the seals.
5. Failure to control labeling and packaging operations to prevent labeling mix-ups and to document the labeling used in the DHR, as required by 21 CFR § 820.120(d). For example, there was no documentation in your device history records to show that the labeling that accompanied your non-sterile product to your contract sterilizer, identified the lot as “non-sterile". Your SOP, PS-0501032 requires that the text, "NON-STERILE WORK IN PROGRESS" accompany the product.
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 FDA 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 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.
Please notify this office in writing within fifteen (15) working days from the date you receive this letter of the specific steps you have taken to correct the noted violations,
including an explanation of how you plan to prevent these violations, or similar violations, from occurring again. Include documentation of the corrective action you have taken. If your planned corrections will occur over time, please include a timetable for implementation of those corrections. If corrective action cannot be completed within 15 working days, state the reason for the delay and the time within which the corrections will be completed.
Your response should be sent to: Karen Archdeacon, Compliance Officer, Food and Drug Administration, One Montvale Avenue, 4th Floor, Stoneham, Massachusetts 02180. If you have any questions about the content of this letter please contact: Karen Archdeacon at (781) 596-7707.
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 closeout of the inspection may be symptomatic of serious problems in your firm's manufacturing and quality assurance 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.
John R. Marzilli
New England District