# FDA 483 - Accu Bio-Chem Laboratories LLC - October 29, 2015

Source: https://www.globalkeysolutions.net/records/483/accu-bio-chem-laboratories-llc/aeeeec20-3977-4fce-8501-a36bbfca2c08

> FDA 483 for Accu Bio-Chem Laboratories LLC on October 29, 2015. 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: 2015-10-29
- Product Type: drugs
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: Accu Bio-Chem Laboratories, a contract testing laboratory in Glendale, CA, was cited for significant deficiencies across its laboratory operations and facility maintenance. The inspection revealed issues with computer system controls and validation, inadequate equipment qualification and calibration, incomplete OOS investigations, and deviations in test procedures and record-keeping. Additionally, the facility itself showed poor repair and unsanitary conditions.

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## Related Officers

- [Bryce Hammer](https://www.globalkeysolutions.net/people/bryce-hammer/57f60d9e-a5f7-4ac4-99d1-c19a1ff8417f)
- [Consumer Safety Officer](https://www.globalkeysolutions.net/people/arie-c-menachem/01bacbef-a3ae-4eb0-a56f-e8a70b67a524)

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