Inspections, Compliance, Enforcement, and Criminal Investigations
GyNova LLC 31-Jan-08
Department of Health and Human Services
Public Health Service
New England District
VIA CERTIFIED MAIL
January, 31 2008
Mr. Don Guinan, Managing Partner
698 Middle Turnpike
Manchester, Connecticut 06040
Dear Mr. Guinan:
During an inspection of your firm located in Manchester, Connecticut on June 11, 26, 27, October 9, 23, and November 5, 2007 an investigator from the United States Food and Drug Administration (FDA) determined that your firm operates as a Specification Developer and Distributor of the G*SPEC Weighted Articulated Vaginal Speculum. 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.
The 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, the 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, (C.F.R.), Part 820. These violations include, but are not limited to, the following:
1. Failure to establish, define and document the procedures to control the design process of the device, as required by 21 CFR 820.30(a).
For example your firm does not have a design control procedure. Two modifications to the device were implemented without a documented rational for the change. During the inspection, you indicated that you made design changes to the device due to complaints that the device was catching on sutures and slipping during surgical procedures. Also, you stated that additional changes were made to increase the strength of the handle to resist bending. Additionally your firm lacked documentation that the changes were approved by a designated individual.
In your response to this Warning Letter, please address how you will be addressing these violations. We need to be assured that your firm will develop and implement an effective design control process that will be implemented immediately.
2. Failure to document process validation activities and results, as required by 21 CFR 820.75(a)
For example, your firm has contracted with [redacted] to provide sterilization of the G-Spec Articulated Weighted Vaginal Speculum. [redacted] documents the sterility validation performed [redacted] using a [redacted]. The certificates of Processing provided [redacted] to document finished product sterilization of GyNova products notes lots M060811A-0911B, M060814A-0911B, M060814A-0911C, M060809A-0911A, M060726A-0911A, and M060726A-0911A received [redacted] on 12/6/2006. Lots M060809A-0911A, M060811A-0911B and M060814A-0911C received [redacted] of radiation on 8/27/2006. There is no documentation the increased dose of radiation was evaluated with respect to the effect on the pouch seals or the product itself.
3. Complaint handling procedures for receiving, reviewing and evaluating complaints have not been established, completed and implemented, as required by 21 CFR 820.198.
For example, your firm does not have complaint handling procedures and does not maintain a record of complaints received by GyNova.
4. Failure to have adequately trained personnel to perform management activities, assessment activities, and audits as required by 21 CFR 820.25(a).
For example, there is no documentation that in your capacity as Managing Partner and sole employee of your firm that you have received any training specific to Medical Device regulations and/or cGMPs which would enable you to evaluate the manufacture or sterilization processes used to manufacture your firm's product.
5. Failure to establish, document and implement procedures to ensure that device history records for each batch, lot, or unit are maintained to demonstrate that the device is manufactured in accordance with the device master record and the quality system regulation, as required by 21 CFR 820.184.
For example, there is no documentation that production records including sterility records for finished devices are reviewed and approved by a designated individual for GyNova, LLC.
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 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: Christopher vanTwuyver, Food & Drug Administration, One Montvale Avenue, Fourth Floor, Stoneham, Massachusetts 02180. If you have any questions about the content of this letter please contact: Christopher at 781 596-7754.
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 (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 violation(s), and take prompt actions to correct the violation(s) and to bring your products into compliance.
Michael R. Kravchuk
Acting District Director
New England District
Attachment: FDA-483 dated November 5, 2007