# FDA 483 - Accu Bio-Chem Laboratories LLC - August 31, 2021

Source: https://www.globalkeysolutions.net/records/483/accu-bio-chem-laboratories-llc/7b7423a8-78b9-4c27-a396-be563bb0d862

> FDA 483 for Accu Bio-Chem Laboratories LLC on August 31, 2021. 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: 2021-08-31
- 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 during an FDA inspection. The firm failed to thoroughly investigate out-of-specification results for OTC drug products, lacked appropriate computer controls to prevent data deletion, and did not ensure laboratory records were reviewed for accuracy and completeness. Additionally, the verification of analytical and microbiology testing methods for OTC drug products was found to be inadequate.

## Related Documents

- [483 - 2015-10-29](https://www.globalkeysolutions.net/records/483/accu-bio-chem-laboratories-llc/aeeeec20-3977-4fce-8501-a36bbfca2c08)
- [WARNING_LETTER - 2021-08-31](https://www.globalkeysolutions.net/records/warning_letter/accu-bio-chem-laboratories-llc/737a7305-f3ca-4555-badd-cab823004269)
- [483 - 2023-02-08](https://www.globalkeysolutions.net/records/483/accu-bio-chem-laboratories-llc/ba1e259e-e669-43b3-be2f-b2506a66b7cf)

## Related Officers

- [Consumer Safety Officer, Drug Specialist](https://www.globalkeysolutions.net/people/taichun-qin/62349336-96d6-4452-9c20-9084204b86bf)
- [Alan L. Truong](https://www.globalkeysolutions.net/people/alan-l-truong/8b9c59ed-ce68-44c3-9fbe-07cc3da13713)

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