Hanbul Cosmetics Co., Ltd MARCS-CMS 546445 —
- Hanbul Cosmetics Co., Ltd
- Issuing Office:
- Center for Drug Evaluation and Research
10903 New Hampshire Avenue
Silver Spring, MD 20993
Via UPS Warning Letter 320-18-42
March 29, 2018
Mr. Cheol Hee Jeong
It’S Hanbul Co., Ltd.; dba Hanbul Cosmetics Co., Ltd.
62, Daeseong-ro 547 Beon-gil
Republic of Korea
Dear Mr. Jeong:
The U.S. Food and Drug Administration (FDA) inspected your drug manufacturing facility, It’S Hanbul Co., Ltd.; dba Hanbul Cosmetics Co., Ltd., 62, Daeseong-ro 547 Beon-gil, Samseong-myeon, Eumseong-gun, Chungcheongbuk-do, from November 27 to December 1, 2017.
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 December 20, 2017, response in detail.
During our inspection, our investigator observed specific violations including, but not limited to, the following.
1. Your firm failed to ensure that laboratory records included complete data derived from all tests necessary to assure compliance with established specifications and standards (21 CFR 211.194(a)).
Your firm could not provide raw data to verify that you performed microbiological finished product testing for your over-the-counter (OTC) drug products.
2. Your firm failed to establish and follow an adequate written testing program designed to assess the stability characteristics of drug products and to use results of such stability testing to determine appropriate storage conditions and expiration dates (21 CFR 211.166(a)).
Your stability studies are inadequate to ensure the OTC drug products you manufacture remain within specification throughout their labeled expiry period. For example, your firm has only conducted six-week accelerated stability studies to support your labeled expiry periods (e.g., (b)(4) or more months). You have not conducted long term stability studies.
Your stability testing program is also inadequate because it does not include an assay determination of the active ingredient(s) in your OTC drug products. Furthermore, it does not include any testing methodology, testing frequency, or information regarding container/closure systems used.
3. Your firm failed to prepare batch production and control records with complete information relating to the production and control of each batch of drug product produced (21 CFR 211.188).
Your batch records do not include significant production details, including but not limited to weights and measurements of raw materials used in the manufacturing process, start and stop times of (b)(4) processes, signatures verifying each significant step in the manufacturing process, and copies of finished product labeling.
4. Your firm failed to use equipment in the manufacture, processing, packing, or holding of drug products that is of appropriate design, adequate size, and suitably located to facilitate operations for its intended use and for its cleaning and maintenance (21 CFR 211.63).
Your firm has not qualified equipment used in the production, packaging, and release testing of your OTC drug products to demonstrate that the equipment is of appropriate design to facilitate operations for its intended use.
Your response is inadequate because it did not provide sufficient evidence of corrective actions to bring your operations into compliance with CGMP. Your response did not include any interim measures to be taken until you complete all proposed corrective actions. Furthermore, your response did not address the effect these violations may have had on OTC drug products within expiry and currently on the U.S. market.
CGMP Consultant Recommended
Based upon the nature of the violations 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. The third-party should comprehensively audit your entire operation for CGMP compliance. Your corrective and preventive actions should be evaluated by the third party to help ensure systemic remediation before you pursue resolution of your firm’s compliance status.
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.
FDA placed your firm on Import Alert 66-40 on March 8, 2018.
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 continuing to refuse admission of articles manufactured at It’S Hanbul Co., Ltd., dba Hanbul Cosmetics Co., Ltd, 62, Daeseong-ro 547 Beon-gil, Samseong-myeon, Eumseong-gun, Chungcheongbuk-do, 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.
Send your electronic reply to CDER-OC-OMQ-Communications@fda.hhs.gov or mail your reply to:
CDR Frank Verni, R.Ph., MPH
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 3006755618.
Office of Manufacturing Quality
Office of Compliance
Center for Drug Evaluation and Research