Curtis Jacquot dba Pacific BioLogic Co.

Warning LetterOpen

Mr. Curtis D. Jacquot President and Owner Curtis Jacquot dba Pacific BioLogic Co. 5514 Langford Ct Concord , CA 94521 United StatesFEI 1000523111Issued Dec 21, 2023Division of Human and Animal Food Operations West V

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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 1000523111.

Violations15

Issue DateDec 21, 2023

Product TypeDietary Supplements

StatusOpen

Letter Details

Firm: Curtis Jacquot dba Pacific BioLogic Co.
Location: Mr. Curtis D. Jacquot President and Owner Curtis Jacquot dba Pacific BioLogic Co. 5514 Langford Ct Concord , CA 94521 United States
FEI Number: 1000523111
Country: United States
Issue Date: December 21, 2023
Issuing Office: Division of Human and Animal Food Operations West V
Product Type: Dietary Supplements
Status: Open

Summary

Curtis Jacquot dba Pacific BioLogic Co. was cited for significant Current Good Manufacturing Practice (CGMP) violations under 21 CFR Part 111 discovered during a June 2023 inspection of their Concord, California dietary supplement manufacturing facility. The company's product labels and websites made disease claims (cure, mitigation, treatment, or prevention) that caused their dietary supplements to be classified as unapproved drugs under the Federal Food, Drug, and Cosmetic Act, and several products were misbranded for lacking adequate directions for use. The company's response to the FDA 483 inspection observations was deemed inadequate, as it only targeted partial corrections and referenced procedures and forms that were not provided for FDA review.

Curtis Jacquot dba Pacific BioLogic Co. FDA Warning Letter, December 21, 2023