- Laboratoire Sintyl S.A.
- Issuing Office:
- Center for Drug Evaluation and Research
| || |
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
| ||10903 New Hampshire Avenue|
Silver Spring, MD 20993
Warning Letter 320-16-37
Return Receipt Requested
September 29, 2016
Mr. Rémy Pfenniger
Laboratoire Sintyl S.A.
Route Des Jeunes 23
Carouge Ge, Geneva, 1227
Dear Mr. Rémy Pfenniger:
The U.S. Food and Drug Administration (FDA) inspected your drug manufacturing facility, Laboratoire Sintyl S.A. at Route Des Jeunes 23, Carouge Ge, Geneva, from June 20 to 23, 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 (FD&C Act), 21 U.S.C. 351(a)(2)(B).
We reviewed your July 5, 2016, response in detail. In that response, you stated that you produced (b)(4) over-the-counter drug and have ceased its manufacture. You did not commit to any corrective actions regarding the CGMP violations observed during the inspection. You committed to (b)(4) and to keeping FDA informed of the (b)(4) progress. You have yet to provide FDA with any evidence to document that a (b)(4) has occurred.
During our inspection, our investigator observed specific violations including, but not limited to, the following.
1. You failed to establish written responsibilities and procedures applicable to the quality control unit, including the review of out-of-specification results and customer complaints. (21 CFR 211.22(d)). During the inspection, you indicated that you have no independent quality unit.
2. You failed to test finished batches of your drug products for the identity and strength of active ingredients. (21 CFR 211.165(a))
3. You failed to ensure the identity of components sourced from various suppliers, including your (b)(4) active ingredients. (21 CFR 211.84(d)(1) and (2))
4. You failed to clean and maintain your (b)(4) at appropriate intervals to prevent malfunctions or contamination of your drug products. (21 CFR 211.67(d)). During the inspection, we observed reddish brown discoloration consistent with rust on your (b)(4).
5. You failed to establish written procedures for production and process controls, including validation protocols and reports, designed to assure that your drug products have the identity, strength, quality, and purity they purport or are represented to possess. (21 CFR 211.100(a)). During the inspection, you acknowledged that your firm has no procedures for process validation.
6. You have no data to demonstrate that the chemical and physical properties of your products remain acceptable throughout their shelf lives. (21 CFR 211.166(a))
You distributed at least (b)(4) batches of (b)(4) Emulsion (b)(4) to the United States, despite the above violations, as well as others cited on the June 23, 2016 Form FDA-483.
CGMP consultant recommended
If your firm resumes manufacturing drugs for the United States 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 the 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 manufacturer.
Failure to correct these violations may also result in FDA refusing admission of articles manufactured at Route Des Jeunes 23, Carouge Ge, Geneva, 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 501(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.
Philip Kreiter, Public Health Analyst
U.S. Food and Drug Administration
White Oak Building 51, Room 4359
10903 New Hampshire Avenue
Silver Spring, MD 20993
Please identify your response with FEI 1000488360.
Office of Manufacturing Quality
Office of Compliance
Center for Drug Evaluation and Research