Recipient NameMr. Hak-Ki Kim
- Barox Co., Ltd.
Number 706, HallaSigma, 545, Dunchon-Daero
- Issuing Office:
- Center for Drug Evaluation and Research
Via UPS Warning Letter 320-19-03
Return Receipt Requested
November 28, 2018
Mr. Hak-Ki Kim
Barox Co., Ltd.
Number 706, HallaSigma, 545, Dunchon-Daero
REPUBLIC OF KOREA
Dear Mr. Kim:
The U.S. Food and Drug Administration (FDA) inspected your drug manufacturing facility, Barox Co., Ltd. at Number 706, HallaSigma, 545, Dunchon-Daero, Jungwon-gu, Gyeonggi-do, Seongnam, from May 17 to 18, 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 Act (FD&C Act), 21 U.S.C. 351(a)(2)(B).
We reviewed your June 7, 2018, response in detail and acknowledge receipt of your subsequent correspondence. Your response is inadequate because it did not provide sufficient evidence of corrective actions to bring your operations into compliance with CGMP.
During our inspection, our investigator observed specific violations including, but not limited to, the following.
- Your firm failed to establish written responsibilities and procedures applicable to the quality control unit (21 CFR 211.22(d)).
Your firm relabels over-the-counter (OTC) drug products made for you by a contract manufacturer. You then distribute these drug products to the United States. You have no written documents describing roles and responsibilities of a Quality Control Unit (QCU). All of your employees, including those in the QCU, lack knowledge of CGMP requirements.
Your response states, "These procedures will be reviewed and approved by the quality unit as below," and the remainder of the document contained 21 CFR part 211 citations quoted verbatim. Your response failed to provide:
- A detailed description of the responsibilities of your QCU.
- Evidence that you have established appropriate written procedures for QCU functions.
- Evidence that your personnel are appropriately trained to perform their assigned function.
- Your firm failed to exercise strict control over labeling issued for use in drug product labeling operations (21 CFR 211.125(a)).
You have no procedures for relabeling operations, including issuance or reconciliation of labels. You relabel at least (b)(4) drug products, including (b)(4) for the U.S. market, without proper labeling controls to prevent labeling mix ups.
Your response failed to provide written procedures for labeling operations performed at your facility. You failed to ensure that relabeling occurs under appropriate CGMP controls.
- Your firm failed to establish and follow written procedures regarding storage and warehousing of drug products (21 CFR 211.142).
You have no procedures for storage and warehousing of drug products, including quarantine storage before release of drug products.
Your response failed to provide written procedures for storage and warehousing. Holding of drug products must be performed under appropriate CGMP controls.
CGMP consultant recommended
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 ensuring ongoing CGMP compliance.
Drugs must be manufactured in conformance with CGMP. FDA is aware that many drug manufacturers use independent contractors, such as production facilities, testing laboratories, packagers, and labelers. FDA regards contractors as extensions of the manufacturer.
You are responsible for the quality of drugs you produce, regardless of agreements in place with your contract facility. You are required to ensure that drugs are made in accordance with section 501(a)(2)(B) of the FD&C Act to ensure safety, identity, strength, quality, and purity. See FDA’s guidance document Contract Manufacturing Arrangements for Drugs: Quality Agreements at https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM353925.pdf.
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 November 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 Barox Co., Ltd. at Number 706, HallaSigma, 545, Dunchon-Daero, Jungwon-gu, Gyeonggi-do, Seongnam, 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:
Lynnsey Renn, 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 3010166805.
Acting Director Office of Manufacturing Quality
Office of Compliance
Center for Drug Evaluation and Research