# FDA 483 - ABR Laboratory LLC - September 13, 2024

Source: https://www.globalkeysolutions.net/records/483/abr-laboratory-llc/71e183ef-8a13-43f2-b421-0b05fefbed1f

> FDA 483 for ABR Laboratory LLC on September 13, 2024. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: ABR Laboratory LLC
- Inspection Date: 2024-09-13
- Product Type: drugs
- Office Name: Florida District Office
- Summary: ABR Laboratory LLC, a control testing laboratory in Hollywood, FL, was cited for significant deficiencies in its microbiological testing methods and quality control unit. The firm failed to validate test methods for OTC drug products, used inadequate in-house media preparation, and did not investigate critical temperature deviations in laboratory equipment. These issues indicate a lack of scientifically sound procedures and proper quality oversight for drug product release testing.

## Related Officers

- [Pharmaceutical Investigator](https://www.globalkeysolutions.net/people/kayla-v-sprague/154cb543-111b-4ad1-b45b-43900df71b90)

Company: https://www.globalkeysolutions.net/companies/abr-laboratory-llc/6cea3443-af0c-4d8d-b428-1086f89d14b3

Office: https://www.globalkeysolutions.net/offices/florida-district-office/95b2a118-0b78-46e0-a54c-982bd7ce51c9