# FDA WARNING_LETTER - West Coast Laboratories, Inc. - October 24, 2023

Source: https://www.globalkeysolutions.net/records/warning_letter/west-coast-laboratories-inc/a44a34af-0b38-494b-ab47-b57dd96a9fe1

> FDA WARNING_LETTER for West Coast Laboratories, Inc. on October 24, 2023. Product: Food. Access full analysis and detailed observations.

---

## Details

- Record Type: WARNING_LETTER
- Company Name: West Coast Laboratories, Inc.
- Inspection Date: 2023-10-24
- Product Type: Food
- Office Name: Division of Human and Animal Food Operations - West V
- Summary: The FDA issued a Warning Letter to a facility in Gardena, CA, following an inspection from October 3-24, 2023. The inspection revealed significant violations of Current Good Manufacturing Practice (CGMP) for dietary supplements (21 CFR Part 111), rendering Calcium Pyruvate, Chromium Picolinate, and CalComplex products adulterated.

Key violations include:
1.  **Lack of Identity Testing:** Failure to conduct identity testing for dietary ingredients like (b)(4), Naticol HPMG, Aquamin F, and Calcium Pyruvate before use, as required by 21 CFR 111.75(a)(1)(i).
2.  **Inadequate Component Specifications:** Failure to establish specifications for purity, strength, and composition of components like (b)(4), Naticol HPMG, Aquamin F, and Calcium Pyruvate, violating 21 CFR 111.70(b)(2).
3.  **Release of Out-of-Specification Product:** Quality control approved and released Calcium Pyruvate Lot 150822 despite an out-of-specification calcium result for a component, violating 21 CFR 111.123(b)(1).
4.  **Premature Component Use:** Components (Aquamin F Lot (b)(4), Calcium Pyruvate Lot (b)(4)) were used in manufacturing before

## Related Officers

- [Darla R. Bracy](https://www.globalkeysolutions.net/people/darla-r-bracy/ff507c75-ede3-4915-9aea-d8971842d891)

Company: https://www.globalkeysolutions.net/companies/west-coast-laboratories-inc/151f0912-77e8-4f35-a2f2-2b8495056a10

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