Robert P. Bailly
Acting CEO
West Coast Laboratories, Inc.
116 E. Alondra Blvd.
Gardena , CA 90248-2806
United StatesFEI 2015768Issued Jun 12, 2024Division of Human and Animal Food Operations West V
Source: FDA, published letter. FDA published this warning letter; View Letter opens FDA's copy. To check it, open FDA's record for this establishment, listed under FEI 2015768.
Violations14
Issue DateJun 12, 2024
Product TypeDietary Supplements
StatusOpen
Letter Details
Firm
West Coast Laboratories, Inc.
Location
Robert P. Bailly
Acting CEO
West Coast Laboratories, Inc.
116 E. Alondra Blvd.
Gardena , CA 90248-2806
United States
FEI Number
2015768
Country
United States
Issue Date
June 12, 2024
Issuing Office
Division of Human and Animal Food Operations West V
Product Type
Dietary Supplements
Status
Open
Summary
West Coast Laboratories, Inc. manufactured adulterated dietary supplements (Calcium Pyruvate, Chromium Picolinate, and CalComplex) in violation of Current Good Manufacturing Practice (CGMP) regulations. During an October 2023 inspection, the FDA identified that the company failed to conduct required identity testing on dietary ingredients prior to use, as mandated by 21 CFR 111.75(a)(1)(i), and did not petition for exemption from such testing. The company's responses to initial inspection observations in November and December 2023 did not adequately address the FDA's specific findings.
West Coast Laboratories, Inc. FDA Warning Letter, June 12, 2024
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