# FDA 483 - Genlabs Corporation - December 09, 2021

Source: https://www.keypedia.com/records/483/genlabs-corporation/36273656-fd1a-4fb5-9066-eae0a565b6c8

> FDA 483 for Genlabs Corporation on December 09, 2021. Product: drugs. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Genlabs Corporation
- Inspection Date: 2021-12-09
- Product Type: drugs
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: Genlabs Corporation, a pharmaceutical manufacturer in Chino, CA, was inspected by the FDA and received a Form 483 with nine observations. The inspection revealed significant deficiencies across quality control, laboratory controls, facilities, equipment, and packaging/labeling systems, including a lack of written procedures, inadequate validation, and issues with product release and equipment maintenance. Several observations were repeats from a previous inspection, indicating persistent non-compliance.

## Related Documents

- [WARNING_LETTER - 2021-12-09](https://www.keypedia.com/records/warning_letter/genlabs-corporation/d7cf09cb-fcad-45a8-9218-f2be56a48f0a)

## Related Officers

- [Claudia M. Perez-Kasmarski](https://www.keypedia.com/people/claudia-m-perez-kasmarski/ee989ba2-eb7a-47ae-8be5-7a28f748343b)
- [https://www.fda.gov/media/120628/download](https://www.keypedia.com/people/santiago-gallardo-johnson/f5086b0c-c8fc-44dd-8d12-6506b9dd313f)

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