# FDA 483 - ABCO Laboratories, Inc. - March 10, 2020

Source: https://www.keypedia.com/records/483/abco-laboratories-inc/15a69543-d5f2-47d7-9333-9509a2c6e832

> FDA 483 for ABCO Laboratories, Inc. on March 10, 2020. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: ABCO Laboratories, Inc.
- Inspection Date: 2020-03-10
- Product Type: drugs
- Office Name: Division of Human and Animal Food Operations - West V
- Summary: ABCO Laboratories, Inc. in Fairfield, CA, a contract manufacturer of over-the-counter drugs, received a Form 483 with three observations. The inspection revealed deficiencies in laboratory controls, specifically the failure to perform required analytical and microbiological testing, and issues with the quality control unit's procedures, including the lack of qualification for a third-party testing laboratory. Additionally, the firm failed to conduct annual product reviews for its OTC drug products.

## Related Documents

- [WARNING_LETTER - 2011-09-09](https://www.keypedia.com/records/warning_letter/abco-laboratories-inc/3808e62e-cc1d-472d-a2dc-968c0ebe0659)

## Related Officers

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

Company: https://www.keypedia.com/companies/abco-laboratories-inc/52a761d4-54be-4be8-a992-bf2c3b4edd8c

Office: https://www.keypedia.com/offices/division-of-human-and-animal-food-operations-west-v/0f4dd01e-8e8a-4336-9abe-ce8b3d309e8b