Vitaganic Inc. 2/8/12
| || |
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
| ||San Francisco District|
1431 Harbor Bay Parkway
Alameda, CA 94502-7070
Delivery Signature Required
February 8, 2012
Cedric P. Ling, Founder and CEO
1275 Reamwood Avenue
Sunnyvale, CA 94089
Dear Mr. Ling:
The U.S. Food and Drug Administration (FDA) conducted an inspection of your dietary supplement manufacturing facility, located at 1275 Reamwood Avenue, Sunnyvale, California from September 9 through October 13, 2011. During the inspection, our investigators found a number of significant violations of the Current Good Manufacturing Practice (CGMP) regulations for dietary supplements, Title 21, Code of Federal Regulations (CFR), Part 111. These CGMP 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 they have been prepared, packed, or held under conditions that do not meet CGMP regulations for dietary supplements. You can find the Act and the referenced regulations through links on FDA's home page at www.fda.gov
Based on the number of employees, your firm became subject to the dietary supplement CGMP regulations on June 25, 2010. Our investigators’ observations were noted on form FDA 483, Inspectional Observations, which was issued to you on October 3, 2011.
The inspection revealed the following violations:
1. You failed to verify that your finished batch of dietary supplements meets product specifications for identity, purity, strength, composition, and for limits on those types of contamination that may adulterate or that may lead to adulteration of the finished batch, as required by 21 CFR 111.75(c). Your Operating Procedure: Product Release, Document No. (b)(4), requires testing of all final products by the QC laboratory. However, statements made by your Senior Vice-President of Manufacturing and Quality Control and our review of your records revealed that you did not conduct appropriate tests or examinations to determine compliance with your specifications, as required by 21 CFR 111.75(c)(2). Your firm only weighs the finished product to ensure that all ingredients were included in the product. This is insufficient because weighing cannot detect contamination in the product and does not ensure purity, strength, or composition. Specifically, you failed to comply with 21 CFR 111.75(c) for the following finished dietary supplements: Vitaganic Marks Health (batch # WO-20119-VG-1) and Vitaganic My Vitamins (batch # WO-20120-VG-1 and WO-20124-VG-1).
We have reviewed your response dated January 18, 2012, indicating that you have written procedures that establish “tight manufacturing controls” and that you have established a “rotating identity testing procedure.” However, your response is inadequate because you did not provide any supporting documentation of your corrective action. Although FDA cannot evaluate the adequacy of your corrective action without this documentation, we note that “tight manufacturing controls” do not appear to verify that your finished batch of dietary supplements meets product specifications for identity, purity, strength, composition, and for limits on those types of contamination that may adulterate or that may lead to adulteration of the finished batch, as required by 21 CFR 111.75(c). In addition, your response states that your “rotating identity testing procedure” will be conducted “[a]t each (b)(4)th order” to verify identity and strength (potency). If “[a]t each (b)(4)th order” means that your procedure will be conducted at every (b)(4)th batch of the formula, your procedure is inadequate because you have not identified a subset of finished dietary supplement batches through a sound statistical sampling plan, as required by 21 CFR 111.75(c).
2. You failed to provide adequate documentation of your basis for why meeting the in-process specifications, in combination with meeting component specifications, will help ensure that the specifications are met for the identity, purity, strength, and composition of the dietary supplements and for limits on those types of contamination that may adulterate or may lead to adulteration of the finished batch of the dietary supplement, as required by 21 CFR 111.70(c)(2). Specifically, your Manufacturing Procedure for Blending of Raw Materials lists an in-process specification, under 21 CFR 111.70(c)(1), of (b)(4) minutes for the blending of raw materials in your (b)(4) Shaker-Mixer. However, when one of our investigators asked how (b)(4) minutes was determined as the blending time to homogenize all mixtures, you failed to provide data to support this specification.
3. Your batch production records (BPR) failed to include complete information relating to the production and control of each batch of your My Vitamins (batch # WO-20124-VG-1 and WO-20120-VG-1) dietary supplement products, as required by 21 CFR 111.255(b). Specifically, your BPRs did not include the following required information:
• The unique identifier that you assigned to each component, as required by 21 CFR 111.260(d). Specifically, your BPRs did not include the unique identifier for the (b)(4) component.
• Documentation, at the time of performance, of the manufacture of the batch, as required by 21 CFR 111.260(j). Specifically, the following information was not documented in your BPRs at the time of performance:
• The initials of the person responsible for weighing or measuring each component used in the batch, as required by 21 CFR 111.260(j)(2)(i);
• 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);
• The initials of the person responsible for adding the component to the batch, as required by 21 CFR 111.260(j)(2)(iii); and
• The initials of the person responsible for verifying the addition of components to the batch, as required by 21 CFR 111.260(j)(2)(iv).
• Documentation at the time of performance that quality control personnel reviewed the BPR, and approved and released, or rejected, the packaged and labeled dietary supplement, including any repackaged or relabeled dietary supplement, as required by 21 CFR 111.260(l)(1) and (4).
We have reviewed your response dated January 18, 2012, indicating that the addition and weights of components are verified by quality control personnel, and that your BPRs have been modified to include the unique identifier assigned to each component. However, your response is inadequate because you did not provide any supporting documentation and batch records for the dietary supplements you manufacture as evidence that you documented the information required by 21 CFR 111.260(j). Without this documentation, FDA cannot evaluate the adequacy of your corrective action.
4. You failed to include in your master manufacturing record (MMR) for your My Vitamins (batch # WO-20124-VG-1 and WO-20120-VG-1) dietary supplement products the following information required by 21 CFR 111.210:
• A complete list of components to be used and an accurate statement of the weight or measure of each component to be used in the production of these batches, as required by 21 CFR 111.210(b) and 21 CFR 111.210(c). Specifically, the capsule ingredients for these products were not listed.
• A statement of any intentional overage amount of a dietary ingredient, as required by 21 CFR 111.210(e).
• Procedures for sampling and a cross-reference to procedures for tests or examinations, as required by 21 CFR 111.210(h)(2).
• Corrective action plans for use when a specification is not met, as required by 21 CFR 111.210(h)(5).
The violations cited in this letter are not intended to be an all-inclusive list of violations that exist at your facility or in connection with your products. It is your responsibility to ensure that all your products are in compliance with the Act and FDA regulations.
You should take prompt action to correct the violations cited in this letter. Failure to promptly correct these violations may result in legal action without further notice including, without limitation, seizure and injunction. FDA may re-inspect your facility to verify that corrective actions have been completed.
In addition to the violations discussed above, we have the following comment:
A firm’s quality control operation must determine whether all components conform to specifications established under 21 CFR 111.70(b) before use in the manufacture of a dietary supplement, as required by 21 CFR 111.120(b), and must approve, and release from quarantine, all components before they are used, as required by 21 CFR 111.120(e). During the inspection, we collected evidence indicating that your dietary supplement components (b)(4) (lot (b)(4)), (b)(4) USP (lot (b)(4)), and (b)(4) (lot (b)(4)) were used to manufacture Healthy Solutions Mind and Body Energy Dietary Supplement (batch # WO-17505-VG-3) on October 4, 2010, Personal Vitamins (batch # WO-17522-VG-1) on October 7, 2010, and Casey’s Multiples (batch # WO-17623-VG-1) on October 22, 2010, respectively. The aforementioned components were sent on November 22, 2010, to a third party laboratory to assay the amounts of the components. These components were therefore used in the manufacture of the products described above prior to the quality control operations on November 22, 2010 determining whether the components met the assay specifications.
Within fifteen working days from receipt of this letter, please notify this office in writing of the specific steps that you have taken to correct these violations, including an explanation of each step being taken to prevent the recurrence of violations and copies of supporting documentation. If you cannot complete corrective action within fifteen working days, state the reason for the delay and the date by which you will have completed the corrections. Additionally, your response should state if you no longer manufacture or distribute products, and provide the date(s) and reason(s) you ceased production.
Please identify your response with FEI #(b)(4) and send your reply to the attention of:
Director, Compliance Branch
U.S. Food and Drug Administration
San Francisco District
1431 Harbor Bay Parkway
Alameda, CA 94502
If you have any questions regarding any issue in this letter, please contact Carl Lee, Compliance Officer at (510) 337-6737, or by fax at (510) 337-6703.