WARNING LETTER
Bill Beauty and Health Products Ltd. MARCS-CMS 555603 —
- Recipient:
-
Recipient NameMr. Kenneth So
- Bill Beauty and Health Products Ltd.
120 Silver Star Blvd
Scarborough, Ontario M1V 4V8
Canada
- Issuing Office:
- Center for Drug Evaluation and Research
United States
| |
10903 New Hampshire Avenue Silver Spring, MD 20993 |
Via UPS Warning Letter: 320-18-68
Return Receipt Requested
August 1, 2018
Mr. Kenneth So
President and CEO
Bill Beauty and Health Products Ltd.
120 Silver Star Blvd
Scarborough, Ontario, M1V 4V8
Canada
Dear Mr. So:
The U.S. Food and Drug Administration (FDA) inspected your drug manufacturing facility, Bill Beauty and Health Products Ltd. at 120 Silver Star Blvd, Scarborough, Ontario, from March 12–16, 2018.
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 (FD&C) Act, 21 U.S.C. 351(a)(2)(B).
In your response of March 29, 2018, you acknowledged the significance of the inspectional observations, and indicated that you will “not be exporting these or any other products that may be regarded as drugs in [the] USA.” Your response provided limited corrective actions and lacked detail regarding specific corrective actions and preventive actions to bring your facility into CGMP compliance.
During our inspection, our investigator observed specific violations including, but not limited to, the following.
1. Your firm failed to have, for each batch of drug product, appropriate laboratory determination of satisfactory conformance to final specifications for the drug product, including the identity and strength of each active ingredient, prior to release. Your firm also failed to conduct, for each batch of drug product, appropriate laboratory testing, as necessary, required to be free of objectionable microorganisms (21 CFR 211.165(a) and (b)).
Your firm released over-the-counter (OTC) drug products to the United States market without testing the identity and strength of each active pharmaceutical ingredient (API). Further, you released these drug products without testing each batch for total microbial count and objectionable microorganisms. Finished product testing is essential to ensuring that each drug product batch manufactured by your firm meets appropriate chemical and microbial specifications.
2. Your firm failed to conduct at least one test to verify the identity of each component of a drug product. Your firm also failed to validate and establish the reliability of your component supplier’s test analyses at appropriate intervals (21 CFR 211.84(d)(1) and (2)).
Your firm failed to perform identity tests on incoming API. Your firm also failed to test incoming API and other components to determine their conformance to purity, strength, and other appropriate specifications. Instead, your firm relied on certificates of analysis (COA) from your suppliers without establishing the reliability of the suppliers’ analysis through appropriate qualification.
3. Your firm failed to establish and follow control procedures to monitor the output and to validate the performance of those manufacturing processes that may be responsible for causing variability in the characteristics of in-process material and the drug product (21 CFR 211.110(a)).
Your firm has not validated the processes used to manufacture your drug products. You failed to perform process qualification studies, and lacked an ongoing program for monitoring process control to ensure stable operations and consistent drug quality.
See FDA’s guidance document, Process Validation: General Principles and Practices, for general principles and approaches that FDA considers appropriate elements of process validation, at https://www.fda.gov/downloads/drugs/guidances/ucm070336.pdf.
CGMP Consultant Recommended
Based upon the nature of the violations we identified at your firm, 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. We also recommend that the qualified consultant perform a comprehensive audit of your entire operation for CGMP compliance, and evaluate the completion and effectiveness of any corrective actions and preventive actions you have implemented before you pursue resolution of your firm’s compliance status with FDA.
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.
Conclusion
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.
Because of the findings of the FDA inspection described in this letter, your firm was placed on Import Alert 66-40 on July 24, 2018.
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 Bill Beauty and Health Products Ltd. at 120 Silver Star Blvd, Scarborough, Ontario, 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, you have 15 working days to respond to this office in writing. 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 completion date and reasons for delay.
Send your reply to:
Rafael Arroyo
Compliance Officer
U.S. Food and Drug Administration
White Oak Building 51, Room 43237
10903 New Hampshire Avenue
Silver Spring, MD 20993
USA
Send your electronic reply to CDER-OC-OMQ-Communications@fda.hhs.gov. Please identify your response with FEI 3006695142.
Sincerely,
/S/
Francis Godwin
Acting Director
Office of Manufacturing Quality
Office of Compliance
Center for Drug Evaluation and Research