# FDA 483 - Alchem Laboratories Corporation - February 14, 2026

Source: https://www.keypedia.com/records/483/alchem-laboratories-corporation/48a7d7a6-12eb-45a1-ae97-400b0e90e435

> FDA 483 for Alchem Laboratories Corporation on February 14, 2026. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Alchem Laboratories Corporation
- Inspection Date: 2026-02-14
- Product Type: drugs
- Office Name: Office of Medical Device and Radiological Health Division II
- Summary: Alchem Laboratories, Corporation, an Active Pharmaceutical Ingredient (API) manufacturer in Alachua, FL, was inspected by the FDA from February 14-16, 2005. The inspection revealed significant deficiencies in material handling, laboratory record-keeping, environmental monitoring, and self-audit procedures. These issues indicate a lack of adherence to established GMP processes and quality assurance protocols.

## Related Officers

- [Sonia M. Monges](https://www.keypedia.com/people/sonia-m-monges/9fd2e517-d456-4c0d-ad4d-02ad9031eebb)

Company: https://www.keypedia.com/companies/alchem-laboratories-corporation/45e8cb80-1a92-437e-a09b-8ee909c73244

Office: https://www.keypedia.com/offices/office-of-medical-device-and-radiological-health-division-ii/ae9bd439-479a-420d-9dd8-9fe1fc0863d6