- Intega Skin Sciences Inc.
- Issuing Office:
- Center for Drug Evaluation and Research
| || |
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
| ||10903 New Hampshire Ave.|
Silver Spring, MD 20993
VIA UPS Warning Letter: 320-17-12
Return Receipt Requested
December 15, 2016
President and CEO
Intega Skin Sciences, Inc.
2805 Place Louis-R.-Renaud
The U.S. Food and Drug Administration (FDA) inspected your drug manufacturing facility, Intega Skin Sciences, Inc. at 2805 Place Louis -R.-Renaud, Laval, Quebec, from May 24 to 27, 2016.
This warning letter summarizes significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals. See 21 CFR Parts 210 and 211.
Because your methods, facilities, or controls for manufacturing, processing, packing, or holding do not conform to CGMP, your drug product is adulterated within the meaning of section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act), 21 U.S.C. 351(a)(2)(B).
We reviewed your June 20, 2016, response in detail, and acknowledge receipt of your subsequent correspondence. In your initial response, you stated that you have ceased manufacturing (b)(4) intended for the U.S. market. You did not provide sufficient detail or evidence to support that your proposed corrective actions will bring your operations into compliance with CGMP prior to resuming manufacturing.
During our inspection, our investigator observed specific violations, including, but not limited to, the following.
1. Your firm failed to thoroughly investigate any unexplained discrepancy or failure of a batch or any of its components to meet any of its specifications, whether or not the batch has already been distributed, and extend investigations to other batches of drug product that may have been associated with the specific failure or discrepancy. (21 CFR 211.192)
For example, you did not investigate the out-of-specification result of 11,000 colony forming units/gram (specification is less than (b)(4) cfu/g) for total aerobic microbial count for lot (b)(4), which you released for distribution, or extend the investigation to other potentially effected lots.
2. Your firm failed to establish written responsibilities and procedures applicable to the quality control unit. (21 CFR 211.22(d))
For example, during the inspection we found that you lacked critical procedures to ensure that you have a functional quality unit, including procedures for review of out-of-specification results, complaint handling, and change control.
3. You failed to ensure that equipment is cleaned at appropriate intervals to prevent contamination and that adequate written cleaning procedures are established. (21 CFR 211.67)
For example, you have not conducted cleaning validation studies to demonstrate your cleaning procedures for non-dedicated production equipment are adequate to prevent contamination.
4. Your firm failed to establish adequate written procedures describing the handling of all written and oral complaints regarding a drug product, including provisions for review by the quality control unit of any complaint involving the possible failure of a drug product to meet any of its specifications and, for such drug products, a determination as to the need for an investigation in accordance with 21 CFR 211.192. (21 CFR 211.198)
For example, your complaint procedures were inadequate to ensure that you receive drug product complaints and investigate them thoroughly.
5. Your firm failed to establish adequate written procedures for production and process control designed to assure that the drug products you manufacture have the identity, strength, quality, and purity they purport or are represented to possess. (21 CFR 211.100(a))
For example, you have not validated the manufacturing processes for your drug products to demonstrate that they are capable of operating within established parameters to assure batch uniformity, integrity, and consistent drug quality.
Despite the above violations, as well as others cited on the Form FDA 483 Inspectional Observations on May 27, 2016, you distributed at least six lots of (b)(4) to the United States.
CGMP consultant recommended
If your firm resumes manufacturing drugs for the U.S. market, we strongly recommend engaging a consultant, qualified as set forth in 21 CFR 211.34, to assist your firm in meeting CGMP requirements. Your use of a consultant does not relieve your firm’s obligation to comply with CGMP. Your firm’s executive management remains responsible for fully resolving all deficiencies and ensuring ongoing CGMP compliance.
Violations cited in this letter are not intended as an all-inclusive list. You are responsible for investigating these violations, for determining their causes, for preventing their recurrence, and for preventing other violations.
Until you correct all violations completely and we confirm your compliance with CGMP, FDA may withhold approval of any new applications or supplements listing your firm as a drug product manufacturer.
Failure to correct these violations may also result in FDA refusing admission of articles manufactured at Intega Skin Sciences, Inc. at 2805 Place Louis.-R.-Renaud, Laval, Quebec, into the United States under section 801(a)(3) of the FD&C Act, 21 U.S.C. 381(a)(3). Under the same authority, articles may be subject to refusal of admission, in that the methods and controls used in their manufacture do not appear to conform to CGMP within the meaning of section 50l(a)(2)(B) of the FD&C Act, 21 U.S.C. 351 (a)(2)(B).
After you receive this letter, respond to this office in writing within 15 working days. Specify what you have done since our inspection to correct your violations and to prevent their recurrence. If you cannot complete corrective actions within 15 working days, state your reasons for delay and your schedule for completion.
Bryce Hammer, Compliance Officer
U.S. Food & Drug Administration
White Oak Building 51, Room 4359
10903 New Hampshire Avenue
Silver Spring, MD 20993
Please identify your response with FEI # 3010603689.
Office of Manufacturing Quality
Office of Compliance
Center for Drug Evaluation and Research