# FDA 483 - Accu Bio-Chem Laboratories LLC - February 08, 2023

Source: https://www.globalkeysolutions.net/records/483/accu-bio-chem-laboratories-llc/ba1e259e-e669-43b3-be2f-b2506a66b7cf

> FDA 483 for Accu Bio-Chem Laboratories LLC on February 08, 2023. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Accu Bio-Chem Laboratories LLC
- Inspection Date: 2023-02-08
- Product Type: drugs
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: An FDA inspection of Accu Bio-Chem Laboratories LLC, a contract testing laboratory in Glendale, CA, revealed significant deficiencies in their quality control unit and equipment management. The firm failed to adequately document out-of-specification results, conduct proper management reviews, and maintain complete written procedures for various quality activities. Additionally, the inspection found a lack of appropriate design and documentation for equipment qualification, specifically for a spectrophotometer system.

## Related Documents

- [483 - 2015-10-29](https://www.globalkeysolutions.net/records/483/accu-bio-chem-laboratories-llc/aeeeec20-3977-4fce-8501-a36bbfca2c08)
- [483 - 2021-08-31](https://www.globalkeysolutions.net/records/483/accu-bio-chem-laboratories-llc/7b7423a8-78b9-4c27-a396-be563bb0d862)
- [WARNING_LETTER - 2021-08-31](https://www.globalkeysolutions.net/records/warning_letter/accu-bio-chem-laboratories-llc/737a7305-f3ca-4555-badd-cab823004269)

## Related Officers

- [Drug Enforcement Administration](https://www.globalkeysolutions.net/people/john-a-gonzalez/51074472-cb23-4b72-8ca7-2d973670063e)

Company: https://www.globalkeysolutions.net/companies/accu-bio-chem-laboratories-llc/5519bf93-f2bf-4a62-9fb5-2fc1a98547b2

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