Inspections, Compliance, Enforcement, and Criminal Investigations
Prostar, Inc. 5/19/11
Department of Health and Human Services
|Public Health Service
Food and Drug Administration
New England District
VIA UPS Next Day Air
May 19, 2011
Mrs. Elizabeth Rubino
7 Corporate Ave
Farmington, CT 06032
Dear Mrs. Rubino:
On November 1, 2010 through November 17, 2010, the U.S. Food and Drug Administration (FDA) inspected your facility located at 7 Corporate Avenue, Farmington, Connecticut. During the inspection, our investigators found a number of 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 Super Complete formula multivitamin tablets, Ultra Ripped capsules, and Higher Power (HP) 100% Whey Powder protein powder 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 current good manufacturing practice regulations for dietary supplements. You may find the Act and FDA regulations through links at FDA's home page at http://www.fda.gov.
The inspection revealed several violations, including:
1. You failed to establish product specifications for the identity and strength, of each finished batch of dietary supplement you manufacture to ensure the quality of the dietary supplement as required by 21 CFR 111.70(e). Specifically:
• You were not able to provide any records to show that you established product specifications of the finished batch for your Ultra Ripped capsules dietary supplement products;
• You were not able to provide any records to show that you established product specifications of the finished batch for your Super Complete dietary supplement products.
We received your response to the FDA 483 dated December 8, 2010. You stated that you are investigating what components you can test in your lab using existing equipment and methods. You also stated that you will begin sending your samples to a third party laboratory for analysis. Your response is inadequate because you did not address your failure to establish product specifications for your finished dietary supplement products, as required by 21 CFR 111.70(e). Further, you did not provide supporting documentation of your corrective action(s).
2. You failed to conduct at least one appropriate test or examination to verify the identity of a component that is a dietary ingredient before using the component, as required by 21 CFR 111.75(a)(1). Specifically:
• (b)(4) of the (b)(4) dietary ingredients used in the manufacture of your Ultra Ripped capsules are not tested for identity; and
• Only (b)(4) of (b)(4) dietary ingredients used in the manufacture of your Super Complete product are tested for identity.
You practice "skip lot testing" whereby you test (b)(4) specific dietary ingredients only every (b)(4) time that you receive those ingredients unless in-process or finished product testing fails. Under 21 CFR 111.75(a)(1), you are required to conduct at least one appropriate test to verify the identity of each dietary ingredient that will be used in the manufacture of a dietary ingredient, unless you petition FDA for an exemption from the testing requirements.
In your December 08, 2010 response, you stated that your "raw material testing program has been in development for some time." Further, you stated that as an interim plan, you may work with a third party lab for identification testing. Your response is inadequate because you did not specify whether you have started conducting an appropriate test or examination to verify the identity of dietary ingredients prior to use, as required by 21 CFR 111.75(a)(1). Further, you did not provide supporting documentation for the proposed corrective action.
3. Your quality control personnel failed to comply with 21 CFR 111.123(b)(1) because they approved and released for distribution dietary supplements that did not meet all product specifications established in accordance with 21 CFR 111.70 e. Specifically, your Super Complete formula multivitamin tablets, (b)(4), were released on November 2, 2010 before finished product testing completed November 05, 2010) revealed out of specification results regarding strength of two ingredients, (b)(4) and (b)(4).
4. You failed to establish and follow written procedures for the responsibilities of the quality control operations, as required by 21 CFR 111.103(a). Specifically, your quality control operations for your master manufacturing record, the batch production record, and manufacturing operations for your Super Complete formula multivitamin tablets and Ultra Ripped capsules failed to include approving and releasing, or rejecting, each finished batch for distribution based on whether the batch meets product specifications, as required by 21 CFR 111.123(a)(8). You released the following dietary supplement products before finished product testing was completed and reviewed:
• Ultra Ripped capsules", was released on October 19, 2010 before finished product testing was completed and reviewed on November 4, 2010; and
• Higher Power 100% Whey Power protein shake, (b)(4), was released on July 23, 2010 before finished product testing was completed and reviewed on October 5, 2010.
In your March 07, 2011 response, you included a "finished product check sheet" that is part of your "BPR release documentation." Your response is not adequate because you did not provide sufficient documentation to confirm implementation of these corrections. Your checklists for batch record review and release titled (b)(4) and (b)(4) both dated November 23, 2010, not completed ,signed, or dated; although you state the updated SOPs and forms are currently in use. We will verify the adequacy of your corrections during the next inspection of your firm.
The above violations are not intended to be an all-inclusive list of deficiencies at your facility. It is your responsibility to ensure that your establishment and the dietary supplement products that you manufacture or distribute meet all of the requirements of the Act and all of its implementing regulations.
Failure to promptly correct the violations specified above may result in enforcement action without further notice. Enforcement action may include seizure of violative products and/or injunction against the manufacturers and distributors of violative products.
In addition to the violations above, we also note the following:
• You do not review all product complaints and investigate those complaints that involve a possible failure of a dietary supplement to meet any of its specifications, as required by 21 CFR 111.560. Further, we note that you do not make and keep records regarding the findings of investigations and follow-up action taken when such investigations are performed, as required in 21 CFR 111.570. In your March 07, 2011 response, you attached a revised product complaint SOP and stated that all product complaints will be investigated. We will verify the adequacy of your corrections during the next inspection of your firm.
• Your Higher Power 100% Whey Power protein shake fails to identify the product using the term "dietary supplement" as a part of the statement of identity as required by 21 CFR 101.3(g).
You must notify this office in writing within 15 working days from your receipt of this letter as to the specific steps that you have taken to correct the above violations and to assure that similar violations will not recur. Your response should include any documentation necessary to show that correction has been achieved. If corrective action cannot be completed within 15 working days, state the reason for the delay and the date by which 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 Compliance Officer Todd Maushart at (781) 587-7486.
Mutahar S. Shamsi
New England District