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Cerebral Health Fails FDA GMP Review
June 7, 2011
3 Min Read
MAITLAND, Fla.FDA found Cerebral Health LLC, Jupiter, FL , failed cGMP (current good manufacturing practice) review during the agencys Feb. 8 to 18, 2011, inspection, according to a warning letter sent to Douglas J. Phillips, II, director of research and development for the company. FDA reported Cerebral Health did not keep adequate records, offer product or ingredient specifications, conduct identity tests or provide written quality control (CQ) documents. As of June 2010, all dietary supplement manufacturers are required by law to follow FDA GMPs.
The letter outlined the violations per 21 CFR Part 111, Current Good Manufacturing Practice (CGMP) regulations for Dietary Supplements, and said failure to comply caused the companys products to be adulterated within the meaning of Section 402(g)(1) [21 U.S.C. § 342(g)(1)] of the Federal Food, Drug, and Cosmetic Act.
FDA noted seven specific violations:
Failure to prepare and follow a written master manufacturing record for each unique formulation and batch size of dietary supplements that Cerebral Health manufactures to ensure uniformity in the finished batch from batch to batch as required by 21 CFR 111.205(a).
Failure to establish product specifications for the identity, purity, strength and composition of each finished batch of the finished dietary supplement products as required by 21 CFR 111.70(e).
Failure to establish identity specifications for each component used in the manufacture of the dietary supplement products as required by 21 CFR 111.70(b)(1).
Failure to either conduct at least one appropriate test or examination to verify the identities of components that are dietary ingredients as required by 21 CFR 111.75(a)(1).
Failure to establish and follow written procedures for the responsibilities of the QC operations, including written procedures for conducting a material review and making a disposition decision, and for approving or rejecting any reprocessing as required by 21 CFR 111.103.
Failure to prepare and keep batch production records for every batch of dietary supplements the company manufactured as required by 21 CFR 111.255.
Failure to establish and follow written procedures to review and investigate product complaints as required by 21 CFR 111.553.
FDA said a company representative verbally confirmed each of these violations during the inspection by saying the company did not have the proper procedures in place.
Cerebral Health sent a response letter to FDA on Feb. 22, 2011, that said the company was in the process of outsourcing manufacturing of all of its bottled products to GMP-compliant contract manufacturers, according to the warning letter. While FDA noted the company gave a verbal timeframe to its investigator for compliance, which would have been mid August 2011, FDA found the response inadequate because it did provided information about the firms manufacturing operations in the interim.
FDA gave Cerebral Health 15 working days to supply the actions the company plans to take in response to the letter, including an explanation of each step being taken to correct the current violations and prevent similar violations.
On the same day the agency sent the warning letter to Cerebral Health, FDA reprimanded Nuvonyx Inc., DBA Real Aloe Inc. and U.S. Aloe, for violating many of the same cGMPs.
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