# FDA WARNING_LETTER - Biotek India - May 25, 2021

Source: https://www.globalkeysolutions.net/records/warning_letter/biotek-india/850bffbd-d7d5-43ba-ac26-50491163b785

> FDA WARNING_LETTER for Biotek India on May 25, 2021. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Biotek India
- Inspection Date: 2021-05-25
- Product Type: Drugs
- Office Name: Center for Drug Evaluation and Research
- Summary: The FDA issued a Warning Letter to Biotek India, an OTC drug manufacturer, following a review of submitted records. The facility's drug products are deemed adulterated due to significant CGMP violations.

Key violations include:
1.  **Failure to test finished drug products (21 CFR 211.165(a)):** Biotek India distributed products, including isopropyl rubbing alcohol, without adequate testing for identity and strength of active ingredients. The FDA requires a list of specifications, an action plan for testing retain samples of all in-expiry batches, and a summary of results, with rapid corrective actions for substandard products. A comprehensive, independent assessment of laboratory practices and a remediation plan are also required.
2.  **Failure to test raw materials (21 CFR 211.84(d)(1)):** The firm did not adequately test incoming raw materials for identity. The FDA requires an independent review of the material system, chemical and microbiological specifications for incoming components, a description of how each component lot will be tested, and a summary of results from testing components to validate supplier COAs.
3.  **Failure to establish an adequate stability testing program (21 CFR 211.166(a)):** Biotek India lacked sufficient stability data, particularly for active ingredient and microbiological stability, to support labeled expiry dates. The FDA requires a comprehensive, independent assessment and CAPA plan for the stability program, including stability-

## Related Officers

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

Company: https://www.globalkeysolutions.net/companies/biotek-india/aeadfd6d-7903-4fab-b2b9-f299f373ed3e

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