# FDA WARNING_LETTER - Cosmecca Korea Co., Ltd. - September 22, 2017

Source: https://www.globalkeysolutions.net/records/warning_letter/cosmecca-korea-co-ltd/c6771901-bd6e-4bc4-8d90-8cd765ca0194

> FDA WARNING_LETTER for Cosmecca Korea Co., Ltd. on September 22, 2017. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Cosmecca Korea Co., Ltd.
- Inspection Date: 2017-09-22
- Product Type: Drugs
- Office Name: Center for Drug Evaluation and Research
- Summary: The FDA issued a Warning Letter to Cosmecca Korea Co., Ltd. following an inspection from September 18-22, 2017, identifying significant violations of current Good Manufacturing Practice (CGMP) regulations for finished pharmaceuticals, rendering their drug products adulterated.

Key violations include:
1.  **Failure to test drug products prior to release (21 CFR 211.165(a)):** The firm released OTC drug products without supporting analytical data for conformance to specifications, and a lab personnel admitted not testing every lot.
2.  **Incomplete laboratory records and data falsification (21 CFR 211.194(a)):** An investigator documented multiple instances of falsified laboratory records, with a quality control employee admitting to manipulating electronic data for untested products. The firm's response indicated the quality assurance manager instructed this manipulation.
3.  **Quality control unit failure to review and approve records (21 CFR 211.192):** Batch records for an OTC sunscreen product contained inaccurate concentration values for active ingredients, leading to the release of an out-of-specification (superpotent) lot.
4.  **Inadequate controls over computer systems (21 CFR 211.68(b)):** Laboratory equipment lacked restricted access, with shared usernames/passwords and administrator rights, preventing traceability of data changes.
5.  **Failure to establish

## Related Officers

- [Director](https://www.globalkeysolutions.net/people/francis-godwin/1556d203-d47c-4744-af37-2591a163149e)

Company: https://www.globalkeysolutions.net/companies/cosmecca-korea-co-ltd/4253fe84-f4f3-408a-b837-8a095755674c

Office: https://www.globalkeysolutions.net/offices/center-for-drug-evaluation-and-research/cd980d74-1cbf-4226-ba9a-9045324c236c