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  1. Compliance Actions and Activities

WARNING LETTER

Engineering Nutrition


Recipient:
Engineering Nutrition


United States

Issuing Office:
Los Angeles District Office

United States


  

Department of Health and Human Services logoDepartment of Health and Human Services

Public Health Service
Food and Drug Administration
 
Los Angeles District
Pacific Region
19701 Fairchild
Irvine, CA 92612-2506
Telephone:    949-608-2900
FAX:    949-608-4415 

 

WARNING LETTER
 
 
 
VIA UNITED PARCEL SERVICE
SIGNATURE REQUIRED
 
August 5, 2014     
                                                                                                                                                            
 
WL # 29-14   
Mr. Guillermo Ramos, Owner
Engineering Nutrition
3516 Seagate Way STE 130
Oceanside, CA 92056
 
Dear Mr. Ramos:
 
The United States Food and Drug Administration (FDA) conducted an inspection of your dietary supplement manufacturing facility, Engineering Nutrition, located at 3516 Seagate Way, STE 130, Oceanside, California from December 10 to December 20, 2013. The inspection revealed serious violations of the FDA’s regulations for Current Good Manufacturing Practice (CGMP) in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements, under Title 21, Code of Federal Regulations (CFR), Part 111 (21 CFR Part 111). These violations cause the dietary supplement products you contract manufacture for (b)(4) 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 requirements for dietary supplements. 
 
Additionally, our investigators collected and reviewed samples of the labeling of your dietary supplement products during the inspection of your facility. Based on our review, your (b)(4) are misbranded under Section 403 of the Act [21 U.S.C. § 343] because they do not comply with FDA’s labeling regulations under 21 CFR Part 101. You can find the Act and FDA regulations through links on the FDA’s home page at http://www.fda.gov.
 
We have received your written response dated December 30, 2013, concerning our investigator’s observations noted on the Form FDA 483, Inspectional Observations, which was issued to you on December 20, 2013. 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 violations, noted below.
 
The significant violations documented during the inspection include, but are not limited to, the following:
 
Dietary Supplement cGMP Violations
 
1.    Your firm failed to establish required specifications for points, steps, or stages 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 master manufacturing record, as required by  21 CFR 111.70(a).
 
Specifically, you failed to establish product specifications for the identity, purity, strength, and composition of the finished batch of the dietary supplements you manufacture, and for limits on those types of contamination that may adulterate, or that may lead to adulteration of, the finished batch of any dietary supplement manufactured by your firm, as required by 21 CFR 111.70(e). 
 
Once you have established the above specifications, you must verify that finished batches of your dietary supplements meet the specifications by complying with the requirements set forth in 21 CFR 111.75(c), and you must make and keep records in accordance with 21 CFR 111.95(b). 
 
In your response dated December 30, 2013, you indicated that you will submit finished product samples to an outside laboratory to be tested to ensure that the finished product meets “manufacturing process” and “formulation” specifications. We find this response inadequate because you did not include any meaningful details, or supporting documentation of your proposed corrections, and you did not provide us with a timeline of completion for your proposed corrections.
 
2.    Your firm failed to confirm the identity of components, other than components that are dietary ingredients, prior to using them in the manufacture of your dietary supplements as required by 21 CFR 111.75(a)(2). To determine whether component specifications are met, you must either conduct appropriate tests or examinations (21 CFR 111.75(a)(2)(i)), or comply with the requirements set forth under 21 CFR 111.75(a)(2)(ii) for relying on suppliers’ certificates of analysis (COAs). Specifically, our inspection revealed that you do not conduct testing for purity, strength, composition, and limits on contamination for all components used to manufacture your finished dietary supplements, as required by 21 CFR 111.75(a)(2).    During our inspection, you failed to provide any documentation that you qualified any of your suppliers in order to rely on their COAs (see 21 CFR 111.75(a)(2)(ii)(C)).
 
In your response dated December 30, 2013, you indicated that upon receiving an ingredient, you will verify suppliers’ COAs by visual, organoleptic, and taste tests, along with sending a sample to an outside laboratory to test for identity, purity, strength, composition, and limits on contamination. We find your response inadequate because you did not include any meaningful details, or supporting documentation of your proposed corrections. Further, you did not provide us with a timeline of completion for your proposed corrections.
 
3.    Your firm failed to prepare and follow a written master manufacturing record for each unique formulation of dietary supplement that you manufacture, as required by 21 CFR 111.205. We note that a master manufacturing record for each unique formulation of a dietary supplement must include the information specified in 21 CFR 111.210.
 
In your response dated December 30, 2013, you indicated that you will implement a MMR for each unique formula for all dietary supplements manufactured by your firm. We find your response inadequate because you did not include any supporting documentation of your corrective action. 
 
4.    You failed to establish written procedures for the responsibilities of the quality control operations, including written procedures for conducting a material review and making a disposition decision, and for approving or rejecting any reprocessing as required by 21 CFR 111.103. Specifically, you do not have written procedures for quality control operations for returned dietary supplements [21 CFR 111.130].
 
In your response dated December 30, 2013, you indicated that you will be establishing procedures, or procedures have already been established. We find your response inadequate because you did not include any supporting documentation of your corrective action. 
 
5.    Your firm also failed to establish and follow written procedures for the following:
 
a.    Product complaints [21 CFR 111.553];
b.    Holding and distributing operations [21 CFR 111.453];
c.    Packaging and labeling operations [21 CFR 111.403].
 
In your response dated December 30, 2013, you indicated that you will be establishing procedures, or procedures have already been established. We find your response inadequate because you did not include any supporting documentation of your corrective action. 
 
6.    Your firm’s batch production records (BPRs) did not include complete information relating to the production and control of each batch of dietary supplement, as required by 21 CFR 111.255(b) and 111.260. Specifically, your firm’s BPRs for (b)(4) did not include a statement of the actual yield and a statement of the percentage of theoretical yield at appropriate phases of processing, as required by 21 CFR 111.260(f).  Specifically, the actual and theoretical yields after the blending and encapsulation operations were not listed on the batch records. 
 
In your response dated December 30, 2013, you indicated that you will begin stating the percentage of the theoretical yield and the actual yield on the BPR for all dietary supplements you manufacture. We find that your response is inadequate because you did not include any supporting documentation of your proposed corrections. Further, you did not provide us with a timeline of completion for your proposed corrections.
 
Misbranded Dietary Supplements
 
Your (b)(4) products are misbranded within the meaning of section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)] in that the products are contained in capsules, but the capsule ingredients are not listed on the label, as required by 21 CFR 101.4(g).
 
This letter is not an intended to be an all-inclusive list of violations in connection with your products. It is your responsibility to ensure that your establishment and your products comply with the Act and its implementing regulations. You should take prompt action to correct all violations noted in this letter. 
 
Failure to promptly correct these violations may result in enforcement action without further notice, such as seizure and/or injunction.
 
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.   You should include in your response documentation and any other useful information that would assist us in evaluating your corrections. 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 the 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, the FDA may assess fees to cover any reinspection-related costs.
 
Your response should be sent to:
 
Acting Director, Compliance Branch
Food and Drug Administration
Los Angeles District Office
19701 Fairchild
Irvine, CA   92612
 
If you have any questions about the content of this letter, please contact Mei-Chen (Jessica) Mu, Compliance Officer, at 949-608-4477. Include Special Identifier FEI #3009712787 on all correspondence.
 
Sincerely,
/S/
Alonza E. Cruse, Director
Los Angeles District
 
 
Cc: 
 
Harlan Loui, Acting Chief
California Department of Public Health
Food and Drug Branch
1500 Capitol Avenue, MS-7602
P.O. Box 997435
Sacramento, CA 95899-7435