# FDA 483 - LabChemS Corp. - February 08, 2024

Source: https://www.keypedia.com/records/483/labchems-corp/d64c0583-ba20-40f7-88cb-a1a22ce639dc

> FDA 483 for LabChemS Corp. on February 08, 2024. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: LabChemS Corp.
- Inspection Date: 2024-02-08
- Product Type: drugs
- Office Name: Division of Human and Animal Food Operations - East IV
- Summary: LabChemS Corp., a contract testing laboratory in Mayaguez, PR, was cited for significant deficiencies during an FDA inspection. Observations included a lack of quality control unit responsibility, inadequate data integrity controls with uncontrolled access to laboratory equipment and expired reagents, and a failure to provide current Good Manufacturing Practice (cGMP) training to Quality Unit employees. These issues indicate a systemic breakdown in quality assurance and compliance.

## Related Officers

- [Angelica M. Hernandez](https://www.keypedia.com/people/angelica-m-hernandez/d66d920c-01b6-4770-a1b5-cac9a1790a0e)

Company: https://www.keypedia.com/companies/labchems-corp/bf8b4b70-52a9-40c5-b0ab-e00e7d595b73

Office: https://www.keypedia.com/offices/division-of-human-and-animal-food-operations-east-iv/a8c8fd15-4e7a-46cb-903a-9980f7ea89e6