Warning Letters Fda

Beehive Botanicals, Inc. 2/8/13
  |   |
Department of Health and Human Services | Public Health Service
Food and Drug Administration |
  | Minneapolis District OfficeCentral Region250 Marquette Avenue, Suite 600Minneapolis, MN 55401Telephone: (612) 334-4100FAX: (612) 334-4142  |
 
February 8, 2013
 
 
WARNING LETTER
 
 
via UPS Overnight Delivery                                  Refer to MIN 13 – 12
 
 
Linda L. Graham
President and Owner
Beehive Botanicals, Inc.
16297 West Nursery Road
Hayward, Wisconsin 54843-7138
 
Dear Ms. Graham:
 
From July 23 – 25, 2012, an investigator from the Food and Drug Administration (FDA) conducted an inspection of your dietary supplement manufacturing plant at 16297 West Nursery Road, Hayward, Wisconsin. The inspectionidentified a number of significant violations of the Current Good Manufacturing Practice (CGMP) regulation for dietary supplements, Title 21, Code of Federal Regulations, Part 111, 21 CFR Part 111. These violations cause your dietary supplement products to be 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 thedietary supplements have been prepared, packed, or held under conditions that do not meet the CGMP regulation for dietary supplements.
 
We received your letter dated August 13, 2012, responding to the form FDA-483, Inspectional Observations, which we issued on July 25, 2012. Overall, your response is inadequate. We have addressed each of your corrective actions below.
                    
Yoursignificant violations include:
 
1.    You failed to establish required specifications for points, steps, or stages in the manufacturing process where control is necessary to ensure the quality of the dietary supplement, as required by 21 CFR 111.70. Specifically:
 
* You failed to establish component specifications for each component that you use in the manufacture of a dietarysupplement, as required by 21 CFR 111.70(b). All components are approved for use in production without having specifications for purity, strength and composition.
* You failed to establish product specifications for the identity, purity, strength, and composition for each dietary supplement you manufacture, as required by 21 CFR 111.70(e). For example, you did not provide any finished productspecifications for strength or composition for your products TheaNAO and Nuke Protect II.
 
In addition, we note that manufacturers are responsible for more than establishing specifications. Once you have established the specifications under 21 CFR 111.70, you must determine whether the specifications have been met as required by 21 CFR 111.73 and 111.75.
 
Your August 13, 2012, response is inadequatefor the following reasons: 
 
(1) Composition cannot be verified by 100% of formulation unless the components and dietary ingredients used in the formulation have been verified to meet specifications which would result in 100% of the labeled amounts.  The instrument you use for testing, (b)(4) does not provide purity, strength or composition analysis. For example, your BoneHealth product labellists Vitamin D at 600 IU per serving, Calcium at 1,000 mg per serving and Magnesium at 500 mg per serving. You cannot ensure meeting these labeled amounts without having created appropriate specifications and then performed the needed testing to ensure such specifications are met;
 
(2) While you have added specifications for the dietary ingredient into your MMR and BPR, you have not addedthe strength and composition of the finished dietary supplement. Your document, identified as “Finished Product Testing,” continues to only include (b)(4) testing, (b)(4) testing, (b)(4); and
 
(3) You have provided no timeframe in which the corrections will be completed.
 
2.    You failed to ensure that the tests or examinations you used to determine whether the specifications are met are...