# FDA 483 - Libby Laboratories, Inc. - March 14, 2025

Source: https://www.keypedia.com/records/483/libby-laboratories-inc/c6bc5f41-1858-4753-b837-5a1c0639d3bb

> FDA 483 for Libby Laboratories, Inc. on March 14, 2025. Product: drugs. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Libby Laboratories, Inc.
- Inspection Date: 2025-03-14
- Product Type: drugs
- Office Name: San Francisco District Office
- Summary: Libby Laboratories, Inc. in Berkeley, CA, a drug manufacturer, was cited for significant deficiencies in its quality control systems during an FDA inspection. Observations included failures to adequately test and release raw materials, perform identification tests for components, and establish the reliability of Certificates of Analysis. Additionally, the firm failed to test finished non-sterile drug products for objectionable microorganisms over the past two years.

## Related Documents

- [WARNING_LETTER - 2025-03-14](https://www.keypedia.com/records/warning_letter/libby-laboratories-inc/84fb09cf-2a95-42d1-a6b4-c5a988838f10)

## Related Officers

- [Nathan E. Hellman](https://www.keypedia.com/people/nathan-e-hellman/88dc6c17-72bf-4c2c-a952-a4ebcd742142)
- [Statistical Science Director](https://www.keypedia.com/people/anney-lin/e1dc45a5-a28f-4636-be13-e9bee6f3bc4e)

Company: https://www.keypedia.com/companies/libby-laboratories-inc/9383702d-87c4-47f8-81dd-08793c3400e1

Office: https://www.keypedia.com/offices/san-francisco-district-office/6f838e9c-aae1-4665-9c46-a51d43be02df