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U.S. Department of Health and Human Services

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Enforcement Actions

Irenda Corporation 4/15/13

  

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

Public Health Service
Food and Drug Administration
 Los Angeles District
19701 Fairchild
Irvine, CA 92612-2506
Telephone: 949-608-2900
FAX: 949-608-4417 

 

WARNING LETTER
 
 
VIA UNITED PARCEL SERVICE
SIGNATURE REQUIRED                                                
 
 
April 15, 2013
                                                                                                                              W/L# 33-13                                                   
Rene D. Daliva, President
Irenda Corporation
14131 Avalon Blvd.
Los Angeles, CA 90061
 
Dear Mr. Daliva:
 
The U.S. Food and Drug Administration (FDA) conducted an inspection of your dietary supplement manufacturing, packaging, and labeling facility, located at 14131 Avalon Blvd., Los Angeles, California from September 12 through 14 and 17, 2012. During the inspection, our investigators identified a number of significant violations of the Current Good Manufacturing Practice (CGMP) regulations for Dietary Supplements, Title 21, Code of Federal Regulations, Part 111 (21 CFR Part 111). These CGMP violations cause your dietary supplement products L-Carnitine, Acetyl L-Carnitine, and Co-Q 10 with L-Carnitine (“your L-Carnitine 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 the dietary supplements have been prepared, packed, or held under conditions that do not meet CGMP regulations for dietary supplements. Our investigators’ observations were presented to you on form FDA-483, Inspectional Observations, at the conclusion of our inspection on September 17, 2012. You may find the Act and FDA regulations through links on FDA’s home page at http://www.fda.gov.
 
The inspection revealed the following significant dietary supplement CGMP violations:
 
1.    Your firm failed to conduct at least one appropriate test or examination to verify the identity of a component that is a dietary ingredient before using the component, as required by 21 CFR 111.75(a)(1)(i). For example, you did not conduct a test or examination to verify the identity of the dietary ingredients used in the following dietary supplements:  
 
Finished dietary supplement/Lot #                       Dietary ingred./ Lot #                         Mfg. date
 
L-Carnitine (b)(4)                                                 L-Carnitine (b)(4)                    (b)(4)
L-Carnitine (b)(4)                                                 L-Carnitine (b)(4)                     (b)(4)
Acetyl L-Carnitine (b)(4)                                     Acetyl L-Carnitine (b)(4)            (b)(4)
Co-Q10 L-Carnitine (b)(4)                                     L-Carnitine (b)(4)                        (b)(4)
 
You have not filed for nor have you received FDA approval for exemption from this requirement, as provided in 21 CFR 111.75(a)(1)(ii).
 
At the time of inspection, you stated that because of the “trust” between you and your customers, you had not tested the ingredients used in the manufacturing of your dietary supplements to verify their identity prior to use; however, this does not exempt you from the requirements of 21 CFR 111.75(a).
 
2.    Your firm failed to confirm the identity of other components (not including dietary ingredients) of your L-Carnitine products and failed to determine whether other component specifications required by 21 CFR 111.70(b) were met, by either conducting appropriate tests or examinations, or relying on a certificate of analysis (COA) from a qualified supplier of the component, as required by 21 CFR 111.75(a)(2). In order to rely on a supplier’s COA you must, among other requirements, first qualify the supplier’s COA through confirmation of the results of the supplier’s tests or examinations, as required by 21 CFR 111.75(a)(2)(ii)(A). Your firm has not qualified any supplier’s COAs.
 
Specifically, you used the COAs from your suppliers for components Glycerin Lot (b)(4), Potassium hydroxide Lot (b)(4), and Citric Acid Lot (b)(4) in the manufacture of the products Co-Q10 L-Carnitine (b)(4), Acetyl L-Carnitine, and L-Carnitine (b)(4), but failed to establish the reliability of the suppliers’ COAs through confirmation of the results of the suppliers’ tests or examinations, as required by 21 CFR 111.75(a)(2)(ii).
 
3.    Your firm failed to verify that a subset of your finished batches of dietary supplements that you identify through a sound statistical sampling plan, or every finished batch, met product specifications for identity, purity, strength, and 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)(1). Our review of your records revealed that your firm released and distributed the following dietary supplements to your customers without performing finished product testing:
 
    • L-Carnitine (b)(4) lot (b)(4)                                                  (b 4)
    • L-Carnitine (b)(4) lot (b)(4)                                                  (b 4)
    • Acetyl L-Carnitine lot (b)(4)                                                   (b 4)
    • Co-Q10 L-Carnitine (b)(4) lot (b)(4)                                     (b 4)
 
4.    Your firm failed to document calibration of equipment, each time the calibration is performed, for instruments and controls that you use in manufacturing or testing a component or dietary supplement, as required by 21 CFR 111.35(b)(3). Specifically, your firm was not able to provide calibration documentation for any of your laboratory equipment (e.g., stability chamber). At the time of inspection, you stated that most of the firm’s equipment is on an annual or semi-annual calibration schedule. However, you were unable to provide documentation of calibration, as required by 111.35(b)(3).
 
5.    Your firm did not hold dietary supplements under conditions that do not lead to the mix-up or contamination of the supplements, as required by 21 CFR 111.455(c). For example, on 9/12/12, our investigator observed the following in the warehouse and production areas of the firm:
 
  • Storage of non-production toxic materials such as anti-freeze in an unlocked cabinet adjacent to released raw materials
  • Unlabeled materials stored throughout the facility
  • Storage of various unlabeled liquid-containing bottles comingled with your firm's liquid dietary supplements.     
 
6.    You failed to maintain your firm’s physical plant in repair sufficient to prevent components, dietary supplements, or contact surfaces from becoming contaminated, as required by 21 CFR 111.15(b)(2). Specifically, our investigator observed that the ceiling above the mixing area, filling lines, and reserve sample area was chipped, peeling, and water stained. Tape and newspaper were being used to stifle pipe leaks. Further, the room in which the water system resides contained standing water from the adjacent sewage drain.
 
7.    You failed to properly store equipment, remove litter and waste, and cut weeds or grass within the immediate vicinity of your facility so that it does not attract and harbor pests, as required by 21 CFR 111.15(a)(1). Specifically, our investigator observed unused equipment (e.g., blenders, mixers, holding tanks) stored on the outside of your facility; the shrubs, weeds, and trees surrounding your facility were not maintained so as to avoid attracting pests; and six unused vehicles were stored adjacent to your facility. The vehicles serve as potential harborage areas for pests.
 
The violations cited above are not intended to be an all-inclusive list of violations at your facility. It is your responsibility to ensure that all of your products are in compliance with the Act and its implementing regulations. You should take prompt action to correct the violations specified above and prevent their reoccurrence. Failure to do so may result in enforcement action by FDA without further notice, including, without limitation, seizure and/or injunction. 
 
In addition, we note that you include “Best if used by” dates on the labels of your firm’s finished dietary supplement products, including your L-Carnitine (b)(4) Flavor, Co-Q 10 (b)(4) with L-Carnitine (b)(4) Flavor, and Acetyl L-Carnitine (b)(4) Flavor products. During the inspection, your laboratory technician informed our investigators that your firm did not conduct studies or have data supporting the “Best if used by” dates listed on your product labels. Any expiration date that you place on a product label (including “best if used by” date) should be supported by data. See 72 Fed. Reg. 34752, 34856 (June 25, 2007).
 
Within fifteen (15) working days from your receipt of this letter, please notify this office in writing of the specific steps you have taken to correct the violations noted above. Include in your response documentation to show that correction has been achieved. If you cannot complete all corrections within 15 working days, please state the reason for the delay and the date by which you will complete the corrections.
 
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.
 
Please send your written response to this letter to:
 
Mr. Blake Bevill
Director, Compliance Branch
United States Food and Drug Administration
19701 Fairchild
Irvine, CA 92612-2506
 
If you have any questions about this letter, please contact Marco S. Esteves, Compliance Officer, at 949-608-4439.
 
Sincerely,
/S/
Alonza E. Cruse, Director
Los Angeles District Office
 
 
Cc:     
Hugo Cornejo, Acting Chief
California Department of Public Health
Food and Drug Branch
1500 Capitol Avenue MS 7602
PO Box 997435
Sacramento, CA 95899-7435
Attn: FDA Correspondence