- Lima & Pergher Industria e Comercio 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
Via UPS Warning Letter 320-16-30
Return Receipt Requested
August 25, 2016
Mr. Fabio Pergher
Lima & Pergher Industria e Comercio S/A
Avenida Airton da Silva 740
Distrito Industrial – Uberlandia
State of Minas Gerais 38402 – 100
Dear Mr. Pergher,
The U.S. Food and Drug Administration (FDA) inspected your drug manufacturing facility, Lima & Pergher Industria e Comercio at Rua Engenheiro Diniz 2069, B. Martins, Uberlandia, State of Minas Gerais, from February 29 to March 3, 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 products are 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 firm’s March 18, 2016, response in detail and acknowledge receipt of your subsequent correspondence.
During our inspection, our investigator observed specific violations including, but not limited to, the following.
1. Your firm failed to establish adequate written responsibilities and procedures applicable to the quality control unit (21 CFR 211.22(d)).
You failed to implement written procedures for the following:
- Responsibility of the Quality Control Unit (QCU) to review and approve all drug product production and control records.
- Responsibility of the QCU unit to handle, review, process, and document change controls, out-of-specification test result investigations, and deviation investigations.
2. Your firm failed to establish and follow appropriate written procedures, designed to prevent objectionable microorganisms in drug products not required to be sterile (21 CFR 211.113(a)).
Your firm failed to perform microbiological testing on each lot of finished product.
3. Your firm approved and released for use one or more lots of components, drug product containers, or closures that did not meet the appropriate written specifications of identity, strength, quality, and purity and related tests under 21 CFR 211.84(d) (21 CFR 211.84(e)).
You used (b)(4) to manufacture finished dosage form drug products. (b)(4) is the minimum acceptable quality standard for manufacture of dosage form products. In addition, the (b)(4) used in the production of (b)(4) must meet appropriate quality standards.
4. Your firm failed to ensure that its drug product bore an expiration date that was supported by appropriate stability testing (21 CFR 211.137(a)).
Your firm had no stability data to support your expiration date.
Use of (b)(4)
During the inspection, we determined that your raw material qualification process was inadequate for your drug products. Specifically, you used (b)(4) in your (b)(4) and (b)(4) products.
(b)(4), results in the drug being deemed adulterated.
CGMP consultant recommended
Your March 18, 2016 response was inadequate. Although you committed to establish written procedures for quality unit responsibilities and stability studies, your response lacked details. You did not include a retrospective review of CGMP deficiencies on the quality of your products already in United States distribution.
Based upon the nature of the violations we identified at your firm, 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 for 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 in all your facilities.
FDA placed your firm on Import Alert 66-40 on July 15, 2016.
Until you completely correct all violations 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 continuing to refuse admission of articles manufactured at Lima & Pergher Industria e Comercio at Rua Engenheiro Diniz 2069, B. Martins, Uberlandia, 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.
William Yang, Ph.D.
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 3004364074.
Office of Manufacturing Quality
Office of Compliance
Center for Drug Evaluation and Research