- Delivery Method:
Mr. Il Chong Chung
- Seindni Co., Ltd.
610-304, 16, Gireum-ro
- Issuing Office:
- Center for Drug Evaluation and Research
Via UPS Warning Letter 320-18-13
Return Receipt Requested
December 5, 2017
Dear Mr. Chung:
The U.S. Food and Drug Administration (FDA) inspected your drug manufacturing facility, Seindni Co., Ltd. at 610-304, 16, Gireum-ro, Seongbuk-gu, Seoul from May 25–26, 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 did not receive a response from your firm to the Form FDA 483 issued at the close of the inspection.
During our inspection, our investigators observed specific violations including, but not limited to, the following.
1. Your firm failed to establish a quality control unit and procedures applicable to the quality control unit with the responsibility and authority to approve or reject all components, drug product containers, closures, in-process materials, packaging materials, labeling, and drug products, including drug products manufactured, processed, packed or held under contract by another company. Your firm failed to establish adequate written responsibilities and procedures applicable to the quality control unit (21 CFR 211.22(a) and (d)).
Your firm lacks an adequate quality unit.
You utilize contract manufacturers to manufacture your over the counter (OTC) drug products distributed to the United States. You explained to our investigator that you make finished product release decisions over the phone with your contract manufacturer, based on whether test results meet pre-established specifications. You do not have procedures covering your batch release process, and your quality unit lacks documentation to demonstrate acceptability of batch manufacturing and product quality.
During the inspection, you confirmed that your contract manufacturers do not make your OTC drug products in conformance with drug CGMP. For example, you have released some drugs for which neither you nor your contract manufacturers conducted release tests for identity and strength of active ingredients. As a result, some of your drugs are distributed without confirmation that they meet specifications for identity and strength of their active ingredients.
In response to this letter, provide your written procedures establishing an adequate quality control unit with the authority to carry out its responsibilities, including, but not limited to:
- Written procedures defining your batch review and release process; and
- Written procedures establishing your supplier and contractor qualification, selection, and oversight program, including procedures to ensure compliance with drug CGMP at all stages of manufacturing, processing, packing, or holding.
Use of Contract Manufacturers
All drugs, including OTC drugs, must be manufactured in conformance with drug 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/guidances/ucm353925.pdf
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 for ensuring ongoing CGMP compliance.
During the inspection, FDA collected (b)(4) OTC drug labels, including labels for sunscreen and skin protectant OTC drug products. As a manufacturer and/or distributer of OTC drug products, it is the responsibility of your firm to comply with all requirements of Federal law and FDA regulations, and to ensure that your products are safe and effective and do not violate the provisions of the FD&C Act.
Products that are marketed and indicated for use as skin protectants, such as (b)(4) are subject to the Final Rule for Skin Protectant Drug Products for Over-the-Counter Human Use (21 CFR 347). If the intent is to market these products as OTC drug products within the scope of FDA’s OTC Drug Review, they must meet the conditions set forth in 21 CFR 347. Otherwise, FDA-approved applications must be in effect.
OTC sunscreen drugs, such as (b)(4) are subject to, among other regulations, the OTC Sunscreen Drug Products; Final Rule Labeling and Effectiveness Testing; Sunscreen Drug Products for Over-the-Counter Human Use, 21 CFR 201.327. Pending the finalization of the Sunscreen Drug Products for Over-the-Counter Human Use [Stayed Indefinitely] monograph, 21 CFR 352, FDA does not object to the marketing of sunscreen products that meet the formulation requirements under 21 CFR 352.10 and 352.20 in addition to all applicable final rules such as 21 CFR 201.327 and 21 CFR 201.66. For example, your SPF products require a Drug Facts panel (21 CFR 201.66) as well as directions and warnings as required by 21 CFR 201.327(e) and 21 CFR 201.327(d) respectively.
Please note that dual language labeling with English and another language is permissible when labeled in accordance to 21 CFR 201.15 and is not otherwise false or misleading. As stated in 21 CFR 201.15, “all words, statements, and other information required by or under authority of the act to appear on the label or labeling shall appear thereon in the English language” and “if the label contains any representation in a foreign language, all words, statements, and other information required by or under authority of the act to appear on the label shall appear thereon in the foreign language.”
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.
On August 23, 2017, FDA placed your firm on Import Alert 66-40.
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 Seindni Co., Ltd. at 610-304, 16, Gireum-ro, Seongbuk-gu, Seoul 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.
Carlos M. González
U.S. Food and Drug Administration
White Oak Building 51, Room 4226
10903 New Hampshire Avenue
Silver Spring, MD 20993
Please identify your response with FEI 3011476755.
Office of Manufacturing Quality
Office of Compliance
Center for Drug Evaluation and Research