Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
New England District
VIA UPS Next Day Air
June 28, 2011
Mr. Gaston J. Levesque
430 Smith St.
Middletown, CT 06457-1531
Dear Mr. Levesque:
During an inspection of your firm located in Middletown, CT on April 25 through May 10, 2011, investigator(s) from the United States Food and Drug Administration (FDA) determined that your firm manufactures sterile, single-use, ophthalmic surgical blades. 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 (C.F.R.), Part 820.
We received a response from Mr. Gaston Steve Levesque, Director of Operations, dated May 23, 2011, concerning our investigator’s observations noted on the Form FDA 483, List of Inspectional Observations that was issued to your facility. We address this response below, in relation to the noted violations. These violations include, but are not limited to, the following:
1. Failure to ensure that when the results of a process cannot be fully verified by subsequent inspection and test that the process shall be validated with a high degree of assurance and approved according to established procedure, as required by 21 CFR § 820.75(a). For example, Your firm failed to re-validate the gamma irradiation sterilization process after significant changes occurred including a new manufacturing location in 2008 and a new blade packaging configuration in 2008.
Your firm failed to qualify equipment and re-validate the manufacturing processes after manufacturing changed physical locations in 2008 including qualification of the package seal machine and validation of the seal process for seal integrity and qualification of the thermal press equipment and validation of the press process used to mount blades to handles.
2. Failure to identify by suitable means the acceptance status of product, to indicate the conformance or nonconformance of product with acceptance criteria. The identification of acceptance status shall be maintained throughout manufacturing, packaging, labeling, installation, and servicing of the product to ensure that only product which has passed the required acceptance activities is distributed, used, or installed, as required by 21 CFR § 820.86
For example, under the contract agreement between your firm and a contract sterilizer, products delivered to the contract sterilizer for sterilization should be identified accordingly as (b)(4) or (b)(4) until the products are confirmed to be sterile by the contract sterilizer’s methods. Your firm does not currently identify products delivered to this contract sterilizer as such.
3. Failure to adequately document acceptance activities, as required by 21 CFR § 820.80(e). For example, your firm’s procedure, (b)(4) states production lots are released from the sterilization house back into your firm’s product inventory utilizing (b)(4), which requires an authorized, dated signature to confirm release. Product lot numbers (b)(4) and (b)(4) were released into your firm’s inventory without an authorized, dated signature once these lots returned to your firm from a contract sterilizer.
We have reviewed your response, dated May 23, 2011, that addressed these violations and find it inadequate. Please provide the associated documentation to the agency as evidence of what corrective actions your firm will be performing in regards to these issues.
You should take prompt action to correct the violation(s) addressed in this letter. Failure to promptly correct these violation(s) 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 violation(s), or similar violation(s), 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.
Please direct your response or any questions you may have to Todd Maushart, Compliance Officer, Food and Drug Administration, One Montvale Avenue, 4th Floor, Stoneham, Massachusetts 02180. His telephone number is (781) 587-7486.
Finally, you should know that this letter is not intended to be an all-inclusive list of the violation(s) at your facility. It is your responsibility to ensure compliance with applicable laws and regulations administered by FDA. The specific violation(s) 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.
Mutahar S. Shamsi
New England District