Inspections, Compliance, Enforcement, and Criminal Investigations
Soluble Products Co., LP
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
Waterview Corporate Center
Telephone (973) 331-4905
March 25, 2011
RETURN RECEIPT REQUESTED
Mr. Stephen M. Hoffman
President and Owner
Soluble Products Co., LP
480 Oberlin Avenue South
Lakewood, NJ 08701-6903
File # 11-NWJ-14
Dear Mr. Hoffman:
On August 2-12, 2010, the U.S. Food and Drug Administration (FDA) inspected your dietary supplement manufacturing facility located at 480 Oberlin Avenue South in Lakewood, New Jersey. Our investigator found serious violations of 21 CFR Part 111, Current Good Manufacturing Practice (cGMP) in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements.
These violations cause your dietary supplements 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 the dietary supplements have been prepared, packed, or held under conditions that do not meet cGMP regulations for dietary supplements. You may find the Act and the FDA's regulations through links in the FDA's home page at http://www.fda.gov.
The inspection revealed the following violations:
1. Your firm failed to establish component identity specifications for each component used in the manufacture of your dietary supplement, as required by 21 CFR 111.70(b)(1). Specifically, your firm did not establish identity specifications for each component used in the manufacture of the following dietary supplements:
• Revival Soy Pro Water Mix Vanilla Unsweetened, lot 04 11RUV A5
• Revival Soy Pro Water Mix Vanilla w/ Sucralose, lots 04 11RUV A5 and B5
• Revival Soy Pro Water Mix Chocolate w/ Sucralose, lot 04 11RAC A5, B5, and C5
• Revival Soy Pro Water Mix Chocolate w/ Fructose, lot 06 11RSC A5 and B5
• Revival Soy Pro Water Mix Vanilla w/ Fructose, lot 06 11RSV A5
• Revival Soy Pro Water Mix Chocolate Unsweetened, lot 10 11RUC A5
2. Your firm's Master Manufacturing Records (MMR) for the Revival Brand Unsweetened Chocolate (lot 10 11 RUCA5) dietary supplements did not include the following information, as required by 21 CFR 111.210:
• The identity and weight or measure of each dietary ingredient that will be declared on the Supplement Facts label and the identity of each ingredient that will be declared on the ingredients list [21 CFR 111.210(d)].
• A statement of the expected yield of the manufactured dietary supplement, including the maximum and minimum percentages of theoretical yield beyond which a deviation investigation of a batch is necessary and material review is conducted, and disposition decision is made. [21 CFR 111.210(f)].
• A description of packaging and a representative label or a cross-reference to the physical location of the actual or representative label [21 CFR 111.210(g)].
• Specifications for each point, step, or stage in the manufacturing process where control is necessary to ensure the quality of the dietary supplement and that the dietary supplement is packaged and labeled as specified in the MMR [21 CFR 111.210(h)(1)].
3. Your firm failed to verify that your finished batch of the dietary supplements meet product specifications for identity, purity, strength, and composition, as required by 21 CFR 111.75(c). Specifically, you did not verify that such finished product specifications were met for the Revival Brand Unsweetened Chocolate (lot 10 11RUCA5). 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)]. However, your firm did not conduct finished product testing to verify that established product specifications were met for such finished dietary supplement products.
4. Your firm failed to establish specifications to provide sufficient assurance that products your firm receives from a supplier for packaging or labeling and distribution as dietary supplements are adequately identified and are consistent
with your purchase order, as required by 21 CFR 111.70(f). Specifically, your firm receives from a supplier 8-count multivitamin blister packs that your firm repackages into finished products for distribution. However, your firm did not establish specifications to provide assurance that the 8-count multivitamin blister packs were adequately identified and consistent with your purchase order, as required by 21 CFR 111.70(f).
We note that your firm does not do its own testing or examination of components that are not dietary ingredients and relies on a certificate of analysis for such components. In addition, we understand that you do not qualify any of the suppliers of such components used in your products by establishing the reliability of the supplier's certificate of analysis through confirmation of the results of their tests or examinations and maintain documentation of how you qualified the supplier. You are required to qualify a supplier that tests or examines components that are not dietary ingredients and maintain documentation of how you qualified the supplier. [21 CFR 111.75(a)(2)(ii)(A), 21 CFR 111.75(a)(2)((ii)(C)].
We also note that your firm does not retain reserve samples for the time required. Reserve samples are required to be retained for 1 year past the shelf life date (if shelf life dating is used), or for 2 years from the date of distribution of the last batch of dietary supplements associated with the reserve sample [21 CFR 111.83(b)(3)]. We understand that your firm retains reserve samples for two years from the date of manufacture.
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.
Please advise this office in writing within 15 days from your receipt of this letter of the specific steps you have taken to correct the violations noted above and to ensure that similar violations do not occur. Your response should include any documentation necessary to show that correction has been achieved. If you cannot complete all corrections before you respond, state the reason for the delay and the date by which you will complete the corrections.
Please send your reply to U.S. Food and Drug Administration, 10 Waterview Blvd., Parsippany, New Jersey 07054, Attn: Joseph F. McGinnis R.Ph, Compliance Officer.
New Jersey District