BioSan Fails to Correct GMP Violations

STONEHAM, Mass.FDA found BioSan Laboratories Inc. failed to correct a  number of cGMPs (current good manufacturing practices) violations found during the agencys Dec. 6, 2010, to Jan. 25, 2011, inspection, according to a letter FDA sent to Carl Jackson, owner and president of the company.

FDA reported BioSan Labs facility in Derry, NH, did not properly handle certain supplements per Title 21, Code of Federal Regulations (CFR), Part 111. The company received a FDA-483 at the conclusion of FDAs inspection on Jan. 25, 2011.

According to the letter, the inspection revealed BioSans Women Over 40 One Daily dietary supplement did not undergo appropriate identity testing or examination. BioSans response letters, dated Feb. 8 and March 23, 2011, were inadequate, according to FDA, because they did not submit documentation that shows implementation of corrective action.

The inspection also found the firms quality control personnel released Adrenal Response dietary supplement, Lot (b)(4), on April 13, 2010, although this lot of finished product failed the finished product specification for standard plate count. Again, FDA found BioSans responses inadequate because while the company indicated the Adrenal Response dietary supplement, Lot #(b)(4) initial test found no pathogens in the product," it did not provide documentation to support this. BioSan also did not submit documentation that shows the company implemented a formal review and documentation system going forward.

FDA also found problems with the companys master manufacturing records (MMRs) for the companys One Daily Women Over 40 dietary supplement, Lot #(b)(4), and Adrenal Response dietary supplement, Lot (b)(4), because they did not include corrective action plans for use when a specification is not met. FDA noted the response provided by the company, which said it will update its MMRs, was inadequate because it did not submit documentation that shows implementation of corrective action.

FDAs inspection found the firm added botanical ingredients to the Women Over 40 One Daily dietary supplement and Adrenal Response dietary supplement that were out-of-specification for its established microbiological specifications. Again, BioSan said it would start to document material review and disposition decisions at the time of performance, but failed to submit documentation that shows implementation of this corrective action.

BioSans batch production record (BPR) did not include complete information relating to the production and control of each batch of its Adrenal Response dietary supplement, Lot #(b)(4), and Women Over 40 One Daily dietary supplement, Lot #(b)(4), as required by 21 CFR 111.255(b). BioSan responded by saying its manufacturing employees were re-trained on how to properly fill out manufacturing documentation, but it did not submit documentation that shows implementation of the corrective action.

FDA also found labeling issues for the Adrenal Refresh dietary supplement in that it contains an undeclared Proprietary Blend," the label fails to identify the part of the Rodiola extract and gooseberry botanical (e .g., root, leaves) used, and the label fails to bear a domestic address or domestic phone number necessary to report a serious adverse event.

BioSans MegaFlora dietary supplement label also had problems, according to FDA, which said it failed to declare vitamin C in the Supplement Facts" panel.

FDA gave BioSans 15 working days of receipt of the letter to provide the steps it has taken to correct the violations.