West Coast Laboratories, Inc.
FDA issued a warning letter to West Coast Laboratories, Inc. (Gardena, CA) following an October 2023 facility inspection, citing serious CGMP violations in the manufacture of Calcium Pyruvate, Chromium Picolinate, and CalComplex dietary supplements. Violations included failure to conduct identity testing on dietary ingredients, inadequate component specifications, releasing products before quality control approval, and deficient batch production records. The products were also found misbranded due to missing adverse event reporting contact information and non-compliant Supplement Facts label formatting. FDA warned that failure to adequately address these issues may result in seizure or injunction.
Flagged claims (4)
The Calcium Pyruvate and Chromium Picolinate products are misbranded within the meaning of section 403(y) of the Act [21 U.S.C. § 343(y)] in that the labels fail to bear a domestic address or domestic phone number through which the responsible person, as described in section 761 of the Act [21 U.S.C. 379aa-1] may receive a report of a serious adverse event with such dietary supplement.
The presentation of the (b)(2)-dietary ingredients is not in the order as set forth in 21 CFR 101.36(b)(2)(i)(B). For example, the declaration of calcium must appear before the declaration of phosphorus.
The label lists calcium pyruvate which is not the nomenclature specified for calcium in 21 CFR 101.9(c)(8) or 21 CFR 101.36(b)(2).
For the Cal Complex product, "Aquamin™" is not the common or usual name for Lithothamnion spp.
Required actions (2)
Please notify FDA in writing, within 15 working days of receipt of this letter, of the specific steps you have taken to address any violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. If you cannot complete corrective actions within 15 working days, state the reason for the delay and the time within which you will do so.
Failure to adequately address this matter may result in legal action including, without limitation, seizure and injunction.
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