Inspections, Compliance, Enforcement, and Criminal Investigations
PurQuality, LLC 12/4/13
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
Los Angeles District
Irvine, CA 92612-2506
VIA UNITED PARCEL SERVICE
December 4, 2013
Ms. Martha M. Christy, CEO
Mr. Faisal Toor, Operations Manager
1895 S. Los Feliz Drive
Tempe, AZ 85281
Dear Ms. Christy:
The U.S. Food and Drug Administration (FDA) inspected your dietary supplement manufacturing facility located at 1895 S. Los Feliz Dr, Tempe, Arizona, from January 14-23, 2013. During the inspection, our investigators found significant violations of FDA’s Current Good Manufacturing Practice (CGMP) regulations for dietary supplements, Title 21, Code of Federal Regulations (CFR), 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 they have been prepared, packed, or held under conditions that do not meet the CGMP regulations for dietary supplements in 21 CFR Part 111. Furthermore, we have determined that your TriMedica Oseto Help™ and TriMedica Pure MSM products are misbranded with the meaning of section 403 of the Act [21 U.S.C. § 343]. You can find the Act and the referenced regulations through links in FDA's homepage at www.fda.gov.
Adulterated Dietary Supplements:
FDA observed the following violations of the CGMP regulations for dietary supplements during the inspection:
1. You failed to establish product specifications for the purity and strength of the finished batch of each dietary supplement you manufacture, and for limits on types of contamination that may adulterate, or that may lead to adulteration of the finished batch of each dietary supplement, as required by 21 CFR 111.70(e). Specifically,
- You did not establish specifications for strength of finished OsteoHelp and PURE MSM capsules.
- You did not establish limits for heavy metal contamination in OsteoHelp and PURE MSM capsules.
We have reviewed your responses, dated January 29, 2013, February 2, 2013, March 11, 2013, and April 4, 2013, and determined that your responses were inadequate. You state in your response letter, dated January 29, 2013, "We have been in the process of testing for purity before and since the January 2012 observation and those tests were shown to the FDA agent, we are continuing this process for the remainder of our products. This process will be completed by May 31, 2013.” Your response letter dated February 6, 2013 makes no reference to this violation.
You state in your letter, dated March 3, 2013, "All reference standards and identity testing materials have been purchased and we are currently waiting for a few standards and chemicals to arrive,” "to complete the identity testing for the Zinc lactate and Dicalcium phosphate.” In your response, dated April 4, 2013, to an update request by FDA dated March 27, 2013, you state, "Strength specifications for MSM 1000 mg has been completed please see exhibit 2." and that "The OsteoHelp has not been completed, but has been completed but has been sent out to a third party lab for strength testing. " However, your responses are deficient because you did not provide sufficient documentation to demonstrate that the testing method you developed for your MSM product is a scientifically valid method. For example, you do not explain how the Fourier Transform Infrared Spectroscopy (FTIR) of MSM can determine the purity and strength of MSM. The same deficiency (absence of scientific validity) applies to OsteoHelp.
2. You did not conduct at least one appropriate test or examination to verify the identity of each incoming dietary ingredient, prior to its use, as required under 21 CFR 111.75(a)(l)(i). Specifically, you did not conduct identity testing for the following incoming dietary ingredients:
- Vitamin D3 100,000 IU PurQuality lot number P50289 used in the manufacturing of the product OsteoHelp finished lot number 13000 (compounding lot number 11634).
- (b)(4) w/ 0.5% silica/methylsulfonylmethane (Dimethyl Sulfone, MSM) PurQuality lot number P 120746 used in the manufacturing of the product MSM I 000 mg capsules finished lot number 1317 6 (compounding lot number 13010).
We have reviewed your responses, dated January 29, 2013, February 2, 2013, March 11, 2013, and April 4, 2013, and determined that your responses were inadequate. You state in your response letter, dated January 29, 2013, "All standards will be purchased no later than by March 1, 2013. Additionally, identity testing for all our raw materials will be done by May 31, 2013." You state in your letter, dated March 3, 2013, "All reference standards and identity testing materials have been purchased and we are currently waiting for a few standards and chemicals to arrive . . . to complete the identity testing for the Zinc lactate and Dicalcium phosphate."
In your response, dated April 4, 2013, to a request for an update from FDA, dated March 27, 2013, you state, "All standards and testing regents for identity testing have been purchased for all raw materials. Composite Reference standards have been created to products that do not have any reference standards available on the market.” However, you have not provided documentation demonstrating that identity testing of the incoming dietary ingredients has been performed using these reference standards.
3. You failed to establish the reliability of the supplier's certificate of analysis through confirmation of the results of the supplier's test or examinations, as required by 21 CFR 111.75(a)(2)(ii)(A), and to maintain documentation of how you qualified the supplier, as required by 21 CFR 111.75(a)(2)(ii)(C). You relied on certificates of analysis (COA) from the suppliers of components used in your dietary supplement products to confirm the identity of these components, but failed to qualify the suppliers of components used in your dietary supplement products by establishing the reliability of the supplier's COA through confirmation of the results of their tests or examinations. Specifically,
- The COA for magnesium stearate, lot #P71099, from raw material supplier (b)(4), contained (b)(4)specifications and test results, and was used to determine if the lot was acceptable for use in the manufacture of OsteoHelp finished lot number 13000. However, the reliability of this COA was not verified as set forth in 21 CFR 111.75(a)(2)(ii).
- The COA for empty hard gelatin capsules, P120952, from raw material supplier (b)(4) contained (b)(4) specifications and test results, and was used to determine if the lot was acceptable for use in the manufacture of PURE MSM finished lot number 13176. However, the reliability of this COA was not verified as set forth in 21 CFR 111.75(a)(2)(ii).
We have reviewed your response letter, dated January 29, 2013, and have determined your response to be inadequate. You state in your letter that you showed your vendor certification packet and several examples of completed vendor certification packets to the investigator during the inspection. You also state that you are continuing to qualify your vendors with the purchased standards which will be completed by December 31, 2013; however, you have not explained why you would need 11 months to qualify your suppliers. You have not provided evidence that you qualified the suppliers listed in the observation above. In addition, your response is not adequate as it does ensure that suppliers are qualified prior to relying on their COAs.
4. Quality control personnel failed to determine whether each finished batch conformed to product specifications established in accordance with 111.70(e), as required by 21 CFR 111.123(a)(7). Specifically, the following finished product lot numbers were released prior to the completion/review of microbiological testing results:
- PURE MSM capsules finished lot number 13176 was released on 10/12/12 and the microbiological results were not completed until 11/12/12.
- OsetoHelp finished lot number 13000 was released on 12/3/12 and the microbiological results were not completed until 12/5/12.
We have reviewed your responses and we will evaluate your implementation of the new SOP during our next inspection of your facility.
5. Your quality control operations for laboratory operations associated with your production and process control system did not include reviewing and approving the results of all tests and examinations required under 21 CFR 111.75, as required by 21 CFR 111.110(c). Specifically, the FTIR notebook used to document raw material and finished product identity results was not reviewed and approved by quality control personnel for the following:
- [(b)(4)] w/0.5% silica/methylsulfonylmethane (Dimethyl Sulfone, MSM) PurQuality lot number P120746 used in the manufacturing of the product PURE MSM finished lot number 13176
- OsteoHelp finished lot number 13000
We have reviewed your response letter, dated January 29, 2013, and have determined your response to be inadequate. You state in your letter that the laboratory notebooks will be reviewed and approved each day, but you did not provide us with any information to demonstrate that this practice is in place.
Misbranded Dietary Supplements:
1. Your TriMedica Oseto Help™ product is misbranded within the meaning of section 403(i)(2) of the Act [21 U.S.C. § 343 (i)(2)] in that the product label fails to declare the common or usual name for the ingredient OsetoGene™ and FOS, as required by 21 CFR 101.36(b)(3).
2. Your TriMedica Oseto Help™ and TriMedica Pure MSM Capsules products are misbranded within the meaning of Section 403(q)(1)(B) of the Act [21 U.S.C. § 343 (q)(1)(B)] because the Supplement Facts panel fails to declare the servings per container, as required by 21 CFR 101.36(b)(1)(ii).
The above is not intended to be an all-inclusive list of violations in connection with your products. You should take prompt action to correct all violations. It is your responsibility to assure your firm complies with all requirements of federal law and FDA regulations. Failure to promptly correct these violations may result in legal action without further notice, including, without limitation, seizure and injunction.
We also offer the following comment:
- You provide an expiration date on your "MASTER PACKAGING BATCH RECORD ROUTER" for your OSTEOHELP 60C, which is the recommended shelf life date of the product as provided by the vendor/manufacturer of the product. Please note that any expiration date, shelf life, or "Best by date "you place on a product label should be supported by stability data [See 72 Fed. Reg. 34752, 34856 (Jun. 25, 2007).
Section 743 of the Act [21 U.S.C. 379j-31] authorizes FDA to assess and collect fees to cover FDA’s costs for certain activities, including reinspection-related costs. A reinspection is one or more inspections conducted subsequent to an inspection that identified noncompliance materially related to a food safety requirement of the Act, specifically to determine whether compliance has been achieved. Reinspection-related costs means all expenses, including administrative expenses, incurred in connection with FDA’s arranging, conducting, and evaluating the results of the reinspection and assessing and collecting the reinspection fees (21 U.S.C. 379j-31(a)(2)(B)). FDA will assess and collect fees for reinspection-related costs from the responsible party for the domestic facility. The inspection noted in this letter identified noncompliance materially related to a food safety requirement of the Act. Accordingly, FDA may assess fees to cover any reinspection-related costs.
We request that you notify this office in writing within 15 working days from your receipt of this letter of the current status of your corrective actions and the specific steps you have taken to correct the noted violations. In your response, include documentation of your corrective actions or steps towards long term, corrective actions. If you cannot complete all corrections before you respond, we expect that you will explain the reason for your delay and please include a timetable for the implementation of any remaining corrections.
Please send your reply to the Food and Drug Administration, Attention:
Blake Bevill, Director
Los Angeles District
Irvine, CA 92612-2506
If you have questions regarding any issues in this letter, please contact David Whitman, Compliance Officer at 619-941-3769
Alonza E. Cruse, Director
Los Angeles District
Martha M. Christy, CEO
P.O. Box 41420
Mesa, AZ 85274.
Hugo Cornejo, Acting Chief
California Department of Public Health
Food and Drug Branch
PO Box 997435
1500 Capitol Avenue, MS-7602
Sacramento, CA 95899-7413
Attn: FDA Correspondence