| Public Health Service Food and Drug Administration |
Central Region |
Department of Health and Human ServicesTelephone (973) 331-4900
November 8, 2010
WARNING LETTER
VIA UPS
11-NWJ-03
Mr. John Botzolakis
President &CEO
Soma Labs, Inc.
248 Wagner Street
Middlesex, NJ 08846
Dear Mr. Botzolakis:
On June 28 through July 8, 2010, the U.S. Food and Drug Administration (FDA) conducted an inspection of your dietary supplement manufacturing facility, Soma Labs, Inc., located at 248 Wagner Street, Middlesex, NJ. The inspection revealed serious violations of the Current Good Manufacturing Practice (CGMP) regulations for Dietary Supplements, Title 21, Code of Federal Regulations (CFR), Part 111. These violations cause your dietary supplement products, identified below, 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 they 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.
Based on the inspection your significant violations are as follows:
1) You failed to determine whether established product specifications for purity, strength, and composition of the finished batches of your dietary supplements identified below were met, as required by 21 CFR 111.73. You may verify that these specifications are met by testing or examining every finished batch or a subset of finished batches for each of the dietary supplements you manufacture [21 CFR 111.75(c)]. If you test a subset of finished batches, you must identify the subset using a sound statistical sampling plan [21 CFR 111.75(c)]. Your standard operating procedure 21.07, Assay Testing of Raw Materials and Finished Products, requires (b)(4) However, our review of your records revealed that you did not conduct any testing to ensure that specifications for purity, strength, and composition were met for the following finished dietary supplements:
a. (b)(4) capsules, lot (b)(4)
b. (b)(4) tablets, lot (b)(4)
c. (b)(4) capsules, lot (b)(4)
d. (b)(4) tablets, lot (b)(4)
e. (b)(4) tablets, lot (b)(4)
In addition, you failed to identify a subset of finished dietary supplement batches through a sound statistical sampling plan that you use to verify that your finished batch of dietary supplement meets all product specifications, as required by 21 CFR 111.75(c). You had no documentation to support your practice of testing" (b)(4) as a statically sound sampling plan.
This letter is not an all-inclusive list of violations at your facility. It is your responsibility to ensure that your establishment and the products you market comply with the Act and 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.
We received your August 18, 2010 response letter to the FDA-483, which was issued to you at the conclusion of our inspection. Although we are not obligated to include your response in our review, because you did not meet the specific response timeframe of 15 working days, we have reviewed your response, and find that it is not adequate. In response to the above violations, you stated that "[t]esting will be performed for every finished product ... [but] [i]f no method is available, a note with an explanation will be made in the analytical report" and you cited 21 CFR 111.75(d)(1). Under 21 CFR 111.75(d)(1), you may exempt one or more product specifications from the verification requirements established in 21 CFR 111.75(c) if you determine and document that the specifications you selected under 21 CFR 111.75(c)(1) are not able to verify that the production and process control system is producing a dietary supplement that meets the exempted product specification and there is no scientifically valid method for testing or examining such exempted product specification at the finished batch stage. In such a case, you must document why any examination or other information will ensure that such exempted product specification is met without verification through testing of the finished batch [21 CFR 111.75(d)(1)]. Your response is inadequate because it does not satisfy the requirements of 21 CFR 111.75(d)(1). Specifically, you did not determine or document, for each dietary supplement for which you exempt one or more product specifications from verification requirements in 21 CFR 111.75(c)(1), what specifications you are selecting and why. In addition, you did not document why such specifications will be met without meeting the verification requirements under 21 CFR 111.75(c)(1) for such dietary supplements to ensure that your finished dietary supplements meet any exempted product specification.
In addition, you included an updated SOP as part of your response. The SOP is not adequate because it does not reference specific in-process and finished product specifications for each product [21 CFR 111.75(c)]. You should review this SOP and determine the specific criteria needed to meet the requirements for when your product specifications have not been met. The other specific corrective actions that you noted in your response will be verified by FDA at our next inspection of your facility.
Within 15 working days of your receipt of this letter, please notify this office in writing of the specifics steps you have taken to correct the violations noted above and to ensure that similar violations do not occur. Include an explanation of each step taken to prevent the recurrence of violations and copies of supporting documentation. If you cannot complete corrective action within 15 days, state the reason for the delay and the date by which you will have completed the corrections.
Your response should be sent to the following address: U.S. Food and Drug Administration, 10 Waterview Boulevard, 3rd Floor, Parsippany, New Jersey 07054, Attn: Sarah A. Della Fave, Compliance Officer. If you have any questions regarding any issue in this letter, please contact Sarah Della Fave at (973) 331-4910.
Sincerely,
/S/
Diana Amador-Toro
Director, New Jersey District
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