Raca Enterprises, Inc. dba Life Cycle Herbal Products 12/14/12
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Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
Los Angeles District
Irvine, California 92612-2506
Telephone (949) 608-2900
Fax (949) 608-4415
VIA UNITED PARCEL SERVICE
December 14, 2012 WL 12-13
Mr. Gregory E. Raco
Mr. Jose L. Castro, Owners
Raca Enterprises, Inc., dba Life Cycle Herbal Products
2746 Durfee Ave. Suite K
El Monte, CA 91732-3471
Dear Mr. Raco and Mr. Castro:
The United States Food and Drug Administration (FDA) conducted an inspection of your dietary supplement manufacturing facility, Raca Enterprises, Inc., dba Life Cycle Herbal Products, located at 2746 Durfee Ave., Suite K, El Monte, California, from August 7 - 20, 2012. The inspection revealed serious violations of FDA’s Current Good Manufacturing Practice (CGMP) in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements regulation, under Title 21, Code of Federal Regulations (CFR), Part 111 (21 CFR Part 111). These violations cause the dietary supplement products you manufacture 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 these products have been prepared, packed, or held under conditions that do not meet CGMP requirements for dietary supplements.
We received your written response, dated August 30, 2012, concerning our investigator’s observations noted on the Form FDA 483, List of Observations, that was issued to you on August 20, 2012. Our comments regarding the adequacy of the actions you took to correct the objectionable conditions and practices observed during the inspection are detailed after the applicable violation, noted below.
The significant violations include, but are not limited to, the following:
1) Your quality control personnel failed to reject the dietary supplement, (b)(4), Lot (b)(4) dated June 19, 2012, for which laboratory results indicated the product did not conform to established specifications, as required by 21 CFR 111.77(a) and 111.123(b)(2). Specifically, your laboratory results for the (b)(4) dietary supplement, Lot (b)(4), dated June 19, 2012 indicated a positive result for E. coli. However, the certificate of analysis for this product specifies “negative” for E. coli, and you shipped this lot to a customer on or about June 22, 2012 with the certificate of analysis stating this lot had negative results for E. coli. It appears that you had this product retested for salmonella on June 25, 2012 and received a negative result on June 28, 2012; however, it was not until the FDA investigator pointed out the positive result for E. coli that you had a retain sample of this product, which you claimed was from the same lot, tested for E. coli. This sample tested negative for E. coli on August 19, 2012.
We have reviewed your response, dated August 30, 2012, and find it inadequate. You indicated that you had your retain sample for this product tested by a 3rd party laboratory to verify the E. coli test and that the results indicate the product was negative for E. coli. However, as noted above, this subsequent test was conducted several weeks after the product had been shipped, and at the time it was shipped your firm had a positive result for E. coli.
2) Your firm failed to create written procedures for the responsibilities of the quality control operations that include written procedures for conducting a material review and making a disposition decision and written procedures for approving or rejecting any reprocessing, as required by 21 CFR 111.103, 111.113 and 111.140(b). While your Standard Operating Procedure (SOP) for Quality Assurance # QMP – 0600 does include language outlining that Quality Assurance is responsible for review and approval, and implementing and monitoring corrective and preventive actions when specifications are not met, you fail to outline the specific procedures your Quality Assurance staff will follow to ensure these responsibilities lead to action. You must include written procedures for your quality control staff, including written procedures for conducting a material review and making a disposition decision. Furthermore, as stated above, the fact that your firm distributed a product, (b)(4), that did not conform to established specifications (laboratory result positive for E. coli), demonstrates that your quality control procedures are not adequate.
3) Your firm failed to conduct at least one appropriate test or examination to verify the identity of a component that is a dietary ingredient, prior to its use, as required by 21 CFR 111.75(a)(1). For example, you did not conduct at least one test or examination to verify the identity of (b)(4) Powder, (b)(4) Powder, and (b)(4) Powder, as required by 21 CFR 111.75(a)(1)(i), nor has FDA received a petition from you, and granted the petition, to exempt you from this testing requirement, as required by 21 CFR 111.75(a)(1)(ii).
We have reviewed your response, dated August 30, 2012, and find it inadequate. Your response states that you will test ingredients for identity starting on November 30; however, you have not provided sufficient details on the testing you will use to verify the identity of components that are dietary ingredients.
4) Your firm did not confirm the identity of other components (not including dietary ingredients) and determine whether other applicable component specifications established in accordance with 21 CFR 111.70 are met by conducting appropriate tests or examinations; or relying on a certificate of analysis (COA) from the supplier of the component that you receive, provided that, among other requirements, you first qualify your component suppliers by establishing the reliability of the suppliers’ COA through confirmation of the results of the suppliers’ tests or examinations, as required by 21 CFR 111.75(a)(2)(ii)(A). Although your written procedure for “Supplier Qualification” states that you qualify your suppliers by submitting “representative samples of the first three lots of components provided and the accompanying certificates of analysis to an independent third party laboratory for confirmation of the results of the supplier’s tests and/or examinations,” our investigator found that you do not submit samples of the first three lots of components to a third party laboratory for confirmation of the results. According to your firm, you qualify your suppliers and your Certificates of Analysis for the components you purchase based on the supplier’s history of compliance, rather than confirmation of the results of their tests or examinations. Furthermore, your firm does not have any documentation of conducting the qualifying procedures outlined in your written procedure for supplier qualification.
We have reviewed your response dated August 30, 2012, and find it inadequate. You state that you will test ingredients beginning on November 30; however, you have not provided sufficient details on how you will confirm the results of the suppliers’ tests or examinations.
5) You failed to prepare and follow a written master manufacturing record (MMR) for each unique formulation of dietary supplement that you manufacture, and for each batch size, to ensure uniformity in the finished batch from batch to batch, in accordance with 21 CFR 111.205. Specifically, you have a document titled “Master Manufacturing Record”; however, this document fails to comply with the requirements of 21 CFR 111.210. You must prepare and follow an MMR, for each formulation and batch size, which includes all elements of 21 CFR 111.210.
We have reviewed your response, dated August 30, 2012, and find it inadequate. Your response fails to address the need for a separate MMR for each unique formulation of dietary supplement that you manufacture, and for each batch size, to ensure uniformity in each finished batch of dietary supplement that you manufacture and also fails to contain all the required elements of 21 CFR 111.210.
6) Your firm failed to verify that your finished batch of dietary supplement 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 of the dietary supplement, as required by 21 CFR 111.75(c). For example, you did not perform finished product testing for identity, purity, strength or composition for your (b)(4) Capsules or (b)(4) Capsules.
We have reviewed your response, dated August 30, 2012, and find it inadequate. You state that you will identify and approve protocols for testing finished dietary supplements; however, your response does not address product currently in the market place, nor does it address product you manufacture prior to the implementation of your revised protocols which you state will begin on November 30, 2012.
7) Your firm failed to prepare a batch production record (BPR) that includes complete information relating to the production and control of each batch of dietary supplement you manufacture, in accordance with 21 CFR 111.255(b) and 111.260. For example, your firm’s BPR for the (b)(4) Capsules, Lot (b)(4) and (b)(4) Capsules, Lot (b)(4) did not include all elements of 21 CFR 111.260.
We have reviewed your response, dated August 31, 2012, and find it inadequate. Your response identifies a timeline that is inadequate in that it will not be complete until November 30, 2012. Furthermore, your response does not address product currently in the market place, nor does it address product you manufacture prior to the implementation of your revised protocols.
You should take prompt action to correct the violations described in this letter. Failure to take appropriate corrective action may result in FDA taking regulatory action without further notice, such as injunction or seizure.
We also offer the following comment:
- We acknowledge that you appear to have made corrections to some observations made by the investigator during the inspection, including the maintenance of the physical plant in a clean and sanitary condition, as well as creating written procedures for in-process specifications for weight checks and executing those procedures to verify that specifications are met. These corrections are critical to ensure the quality of the dietary supplements that you manufacture and we will work with your firm to evaluate your improvements during future inspections.
Please respond in writing within fifteen (15) working days from your receipt of this letter. Your response should outline the specific actions you are taking to correct these violations and to prevent similar violations from occurring in the future. If you cannot complete all corrections before you respond, you should explain the reason for your delay and state when you will correct any remaining violations.
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)]. For a domestic facility, 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.
Your response should be sent to:
Director, Compliance Branch
Food and Drug Administration
Los Angeles District Office
Irvine, CA 92612
If you have any questions about the content of this letter, please contact Dr. William Vitale, Compliance Officer, at 949-608-2919.
Alonza E. Cruse, Director
Los Angeles District
Cc: Ingeborg Small
Food and Drug Branch
California Department of Public Health
1500 Capitol Avenue - MS 7602
P.O. Box 997413