# FDA WARNING_LETTER - Genlabs Corporation - December 09, 2021

Source: https://www.keypedia.com/records/warning_letter/genlabs-corporation/d7cf09cb-fcad-45a8-9218-f2be56a48f0a

> FDA WARNING_LETTER for Genlabs Corporation on December 09, 2021. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Genlabs Corporation
- Inspection Date: 2021-12-09
- Product Type: Drugs
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: The FDA inspected Genlabs Corporation from November 29 to December 9, 2021, identifying significant CGMP violations, rendering drug products adulterated. The "FIRST STREET Dishwashing Concentrate & Antimicrobial Hand Soap" product was also deemed misbranded.

Key violations include:
1. **Inadequate Cleaning Procedures (21 CFR 211.67(b)):** The firm uses the same equipment for drug and hazardous non-pharmaceutical products without adequate cleaning procedures, posing a cross-contamination risk. This is a repeat observation from 2017. The FDA requires a risk assessment for all affected drugs, a plan for manufacturing separation, and improvements to cleaning validation.
2. **Insufficient Laboratory Controls (21 CFR 211.165(a), (b), (e)):** Drug products were released without complete final testing, and analytical test methods lacked proper validation. This is a repeat observation. The FDA demands a list of specifications, a plan for testing retain samples, and an independent assessment of laboratory practices.
3. **Failure in Production and Process Control (21 CFR 211.100(a)):** The water system for drug manufacturing is unvalidated, and process validation for OTC drug products is lacking. This is a repeat observation. The FDA requires a comprehensive water system remediation plan, including testing for *Burkholderia cepacia complex*, and a detailed process validation program.

## Related Documents

- [483 - 2021-12-09](https://www.keypedia.com/records/483/genlabs-corporation/36273656-fd1a-4fb5-9066-eae0a565b6c8)

## Related Officers

- [Compliance Officer](https://www.keypedia.com/people/rumany-c-penn/021eb1e0-8de0-403f-9596-3e76624b2e5a)
- [Program Division Director](https://www.keypedia.com/people/steven-e-porter/5448db0e-32f0-4e98-8a5f-9f0857373b06)

Company: https://www.keypedia.com/companies/genlabs-corporation/d064f8a7-2b33-40d0-b1c9-02465de0f974

Office: https://www.keypedia.com/offices/division-of-pharmaceutical-quality-operations-iv/a2d2ff91-dc0f-433e-b91f-ca90ff8998b6