| Public Health Service Food and Drug Administration |
New England District |
Department of Health and Human Services
WARNING LETTER
NWE-21-11W
VIA United Parcel Service
June 17, 2011
Mr. Carl Jackson
Owner and President
BioSan Laboratories, Inc.
8 Bowers Road
Derry, NH 03038
Dear Mr. Jackson:
During a December 6, 2010 through January 25, 2011 inspection of your firm located at 8 Bowers Road, Derry, New Hampshire, investigators from this office performed an inspection and found a number of significant violations of Current Good Manufacturing Practice (cGMP) regulations in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements, Title 21, Code of Federal Regulations (CFR), Part 111.
The inspection revealed that your Women Over 40 One Daily dietary supplements and Adrenal Response dietary supplements are adulterated within the meaning of section 402(g)(1) of the Federal Food, Drug and Cosmetic Act (the Act) [21 U.S.C. 342(g)(1)] in that the dietary supplements have been prepared, packed, or held under conditions that do not meet cGMP regulations for dietary supplements. These observations were presented to you in an FDA-483 at the conclusion of our inspection on January 25, 2011.
Further, our review of your product labeling revealed that your Megaflora and Adrenal Refresh dietary supplements are misbranded within the meaning of section 403 of the Act [21 U.S.C. § 343].
Adulterated Dietary Supplements
The inspection revealed the following violations:
1. Your firm failed to conduct at least one appropriate test or examination to verify the identity of a dietary ingredient prior to its use, to comply with 21 CFR 111.75(a)(1)(i). Specifically, your firm used dietary ingredients (vitamins and minerals) in the One Daily Womens Over 40 Blend, and additional dietary ingredients (botanicals) to manufacture the finished product Women Over 40 One Daily dietary supplement, Lot #(b)(4). However, with the exception of (b)(4) your firm did not perform an appropriate identity test or examination on any vitamins, minerals, or botanicals prior to the use of the dietary ingredient components in the manufacture of Women over 40 One Daily dietary supplement, Lot (b)(4).
We have reviewed your responses dated February 8 and March 23, 2011, in which you state that you have implemented identity testing for dietary ingredients. Your response is inadequate because you did not submit documentation which shows implementation of this corrective action.
2. Under 21 CFR 111.123(b)(2), no finished batch of dietary supplements may be released for distribution unless it meets all product specifications established in accordance with 21 CFR 111.70(e). However, your firm’s quality control personnel released finished batches of dietary supplements which did not conform to product specifications established in accordance with 21 CFR 111.70(e). Specifically, your firm’s 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. Your analytical result indicated (b)(4), but your specification was listed as less than (b)(4).
We have reviewed your responses dated February 8 and March 23, 2011 and determined them to be inadequate. You indicated that the Adrenal Response dietary supplement, Lot #(b)(4) initial test found “no pathogens in the product.” However, you provided no documentation to support this. You also state that the release of Adrenal Response dietary supplement, Lot (b)(4), was allowed after a management review. However, you did not include the documentation regarding this management review, any justification for release of the product, or information on any treatment or reprocessing conducted to ensure quality of the finished batch for our evaluation. We note that you state that you will implement a formal review and documentation system going forward, however, you did not submit documentation which shows implementation of this corrective action.
3. You failed to reject, reprocess, or approve a treatment or in-process adjustment for components that failed to meet established microbial specifications to ensure the quality of the finished dietary supplements, as required by 21 CFR 111.77(a) and 111.113(b)(2). Specifically, you used the following out-of-specification components in the manufacture of (b)(4) lots of dietary supplements:
(b)(4)
Adrenal Response dietary supplement, Lot (b)(4)
We have reviewed your responses dated February 8 and March 23, 2011 and determined them to be inadequate. You stated that your quality control personnel have the discretion to (b)(4) with an acceptable method to reduce (b)(4).” Calculating a component’s contribution to (b)(4) is not an in-process adjustment. You are required to reject components that do not meet established specifications and to not use them in the manufacture of your finished product unless your quality control personnel approves a treatment, an in-process adjustment, or reprocessing of the out-of-specification components.
4. The written instructions in your master manufacturing records (MMRs) did not include corrective action plans to use when a specification is not met, in accordance with 21 CFR 111.210(h)(5). Specifically, the MMRs for your One Daily Women Over 40 dietary supplement, Lot #(b)(4), and Adrenal Response dietary supplement, Lot (b)(4), did not include corrective action plans for use when a specification is not met.
We have reviewed your responses dated February 8 and March 23, 2011, in which you state that you will update your MMRs including the addition of corrective action plans within 180 days. However, you did not submit documentation which shows implementation of this corrective action.
5. Your film failed to make and keep documentation of any material review and disposition decision and follow-up, as required by 21 CFR 111.140(b)(3). Specifically, our review of the batch records for the Women Over 40 One Daily dietary supplement, Lot #(b)(4), and Adrenal Response dietary supplement, Lot #(b)(4), showed that you added (b)(4) botanical ingredients in the Women Over 40 One Daily dietary supplement and (b)(4) botanical ingredient in Adrenal Response dietary supplement that were out-of-specification for your established microbiological specifications during your blending operations. However, you did not provide documentation of any material review and disposition decision and follow-up for these deviations from specifications. You must document material review and disposition decisions and follow-up in accordance with the requirements of 21 CFR 111.140(b)(3), including the requirement that you identify the specific deviation or the unanticipated occurrence [21 CFR 111.140(b)(3)(i)]; describe your investigation into the cause of the deviation from the specification or the unanticipated occurrence [21 CFR 111.140(b)(3)(ii)]; evaluate whether or not the deviation or unexpected occurrence has resulted in or could lead to a failure to ensure the quality of the dietary supplement [21 CFR 11.140(b)(3)(iii)]; identify the actions taken to correct, and prevent a recurrence of, the deviation or unanticipated occurrence [21 CPR 111.140(b)(3)(iv)]; explain what you did with the component, dietary supplement, packaging, or label [21 CFR 111.140(b)(3)(v)]; and explain a scientifically valid reason for any reprocessing of a dietary supplement that is rejected or any treatment or in-process adjustment of a component that is rejected [21 CFR 111.140(b)(3)(vi)].
We have reviewed your responses dated February 8 and March 23, 2011, in which you state that you will document material review and disposition decisions at the time of performance. Your response is inadequate because you did not submit documentation which shows implementation of this corrective action.
6. Your batch production record (BPR) did not include complete information relating to the production and control of each batch of your 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). Specifically, your BPR for your Adrenal Response dietary supplement, Lot #(b)(4), did not include the following required information:
o Documentation, at the time of performance, of the manufacture of the batch, including the initials of the person responsible for verifying the weight or measure of each component used in the batch, as required by 21 CFR 111.260(j)(2)(ii).
Additionally, your BPR for your Women Over 40 One Daily dietary supplement, Lot #(b)(4) did not include the following required information:
o Identity of equipment and processing lines used in producing the batch, as required by 21 CFR 111.260(b). Specifically, your batch record for the blending operation did not identify the blender (i.e., blender id) used to produce this lot.
We have reviewed your responses dated February 8 and March 23, 2011, in which you state that your manufacturing employees were re-trained on how to properly fill out manufacturing documentation and provide their training record. However, you did not submit documentation which shows implementation of the corrective action.
Misbranded Dietary Supplements
1. Your MegaFlora dietary supplement is misbranded within the meaning of section 403(q)(5)(F) of the Act [21 U.S.C. § 343(q)(5)(F)] because the label fails to declare the dietary ingredient, Vitamin C, when it is present in a quantitative amount that exceeds the amount that can be declared as zero in the “Supplement Facts” panel, as required under 21 CFR 101.36(b)(2). Your Vitamin C dietary ingredient is declared under “other ingredients” on your product label, however, Vitamin C is not declared in the “Supplement Facts” panel.
2. Your Adrenal Refresh dietary supplement is misbranded within the meaning of section 403(q)(5)(F) of the Act [21 U.S.C. § 343(q)(5)(F)] in that your product contains the proprietary blend of a combination of (b)(4) and (b)(4), but it is not identified in the supplement facts panel on your label as required by 21 CFR 101.36(c). Under 21 CFR 101.36(c), a proprietary blend of dietary ingredients must be identified by the term “Proprietary Blend” or other appropriately descriptive term or fanciful name in the supplement facts panel. Although your label bears the term “Additional Foods and Extracts 145mg” in the supplement facts panel, this term does not comply with 21 CFR 101.36(c).
3. Your Adrenal Refresh dietary supplement is misbranded within the meaning of section 403(s)(2)(C) of the Act [21 U.S.C. § 343(s)(2)(C)], in that the label fails to identify the part of the plant (e .g., root, leaves) from which botanical dietary ingredients in the product is derived, as required by 21 CFR 101.4(h)(1). For example, your product lists the ingredients Rodiola extract and gooseberry, but does not identify the part of the plants used.
4. Your product Adrenal Refresh dietary supplement is misbranded within the meaning of section 403(y) of the Act [21 U.S.C. § 343(y)] in that the label fails to bear a domestic address or domestic phone number through which the responsible person may receive a report of a serious adverse event associated with such dietary supplement.
The above violations are not intended to be an all-inclusive list of deficiencies. It is your responsibility to ensure that the products that you manufacture or distribute meet all of the requirements of the Act and its implementing regulations.
Failure to promptly correct the violations specified above may result in enforcement action without further notice. Such action may include, but is not limited to, seizure or injunction.
We note that your firm’s quality control personnel failed to approve written procedures that may affect the identity, purity, strength, or composition of a dietary supplement, as required by 21 CFR 111.105(a). Specifically, your firm’s Standard Operating Procedure (b)(4), for determining the disposition of raw materials, in-process, and finished products was not signed and approved by your firm’s quality control personnel.
We also note that under section 761(c) of the Act, you must submit a report of a serious adverse event associated with any of your dietary supplements no later 15 business days after a report of the event is received through the address or phone number provided on your dietary supplement products. Because prompt submission of such serious adverse event reports is important for public health reasons, the agency recommends that all serious adverse events be reported to FDA within 15 business days of receipt regardless of the means by which you receive the initial report. These serious adverse event reports must be submitted under the MedWatch Form 3500A. More information on adverse event reporting can be found online in the publication “Questions and Answers Regarding Adverse Event Reporting and Recordkeeping for Dietary Supplements as Required by the Dietary Supplement and Nonprescription Drug Consumer Protection Act” available on our website, www.fda.gov.
We have reviewed your March 23, 2011 response to observation 6 in the FDA-483 and acknowledge your submission of the FDA adverse event report for the serious adverse event reported to you on October 8, 2010, but not reported to FDA by you until February 8, 2011.
Please notify this office in writing within 15 working days of receipt of this letter as to the steps that you have taken to correct the above-listed violations and to assure that similar violations will not recur. Your response should include any documentation necessary to show that the correction has been achieved. If corrective action cannot be completed within 15 working days, state the reason for the delay and the time within which the corrections will be made. Address your reply to the U.S. Food and Drug Administration, One Montvale Avenue, Stoneham, MA 02180, Attention: Todd Maushart, Compliance Officer. If you have any questions about the content of this letter please contact: Todd Maushart at (781) 587-7486.
Sincerely,
/S/
Mutahar S. Shamsi
District Director
New England District
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