Inspections, Compliance, Enforcement, and Criminal Investigations
SciLabs Nutraceuticals 1/25/13
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
Los Angeles District
Irvine, CA 92612-2506
VIA UNITED PARCEL SERVICE
January 25, 2013 WL# 18-13
Mr. Paul Edalat, President
Scilabs Nutraceuticals, Inc.
17809 Gilette Ave
Irvine, CA 92614-6501
Dear Mr. Edalat:
The U.S. Food and Drug Administration (FDA) inspected your dietary supplement manufacturing facility, located at 17809 Gilette Ave., Irvine, CA, on July 31, 2012 through August 14, 2012. The inspection identified serious violations of FDA’s Current Good Manufacturing Practice (CGMP) regulations in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements, Title 21, Code of Federal Regulations, Part 111 (21 CFR Part 111). These violations cause your dietary supplement products to be adulterated under section 402(g)(1) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 342(g)(1)] because they have been prepared, packed, or held under conditions that do not meet the CGMP regulation for dietary supplements.
The inspection also revealed violations of dietary supplement labeling requirements, rendering your Duzoxin Secret to Slim, Punishment Nutrition and Whey Protein Isolate products misbranded within the meaning of Section 403(y) of the Act [21 U.S.C. § 343(y)].
You may find the Act and its implementing regulations through links on FDA’s home page at www.fda.gov.
Dietary Supplement CGMP Violations
- Your firm did not establish required specifications for points, steps, or stages in the manufacturing process where control is necessary to ensure the quality of the dietary supplement, as required by 21 CFR 111.70.
Once you have established the above specifications, you must determine whether the specifications have been met, as required by 21 CFR 111.73 and 111.75.
- Before using components in manufacturing your dietary supplements, you failed to meet the requirements of 21 CFR 111.75(a). For example:
- You did not conduct at least one appropriate test or examination to verify the identity of any component that is a dietary ingredient, as required by [21 CFR 111.75(a)(1)(i)]. Specifically, your firm did not test or verify the identity of the Instant Whey Protein and Glutamine used to manufacture your N-Large 2 and Nutritech products.
- You did not confirm the identity of other components, as required by [21 CFR 111.75(a)(2)]. Specifically, your firm relied on your suppliers’ Certificate of Analysis (COA), but you have not qualified the suppliers, of the Maltrin, Maltodextrin, Fructose, Sucralose components used in your N-Large 2 product and Flo-Gard AB, Magnesium Stearate, Rice White Flour, and Clear Bovine Capsules components used in your Nitrogen Glutamine capsules.
We have reviewed your response, dated September 5, 2012, and found it to be inadequate. You state that you will issue testing specifications for incoming dietary ingredients as well as update your current raw material supplier verification program to reflect the updated qualification of ingredient suppliers. However, you did not provide the proposed testing specification or any adequate supporting documents to evaluate your corrective actions.
- Your firm did not prepare and follow a written master manufacturing record for each unique formulation of a dietary supplement that you manufactured, as required by 21 CFR 111.205 and in accordance with 21 CFR 111.210.
We have reviewed your response, dated September 5, 2012, and found it to be inadequate. You have submitted a SOP but you failed to include an example of the document that will be maintained as your firm’s master manufacturing record.
- Your firm failed to complete a batch production record every time you manufactured a batch of dietary supplement as required by 21 CFR 111.255. For example, the batch production record for your N-Large2 (Lot# 10EN2C03122) fails to contain the following information required by 21 CFR 111.260:
a. The batch, lot or control number for each material, packaging, and labeling used to manufacture the finished dietary supplement [21 CFR 111.260(a)(2)].
b. The identity of equipment and processing line used in producing the batch [21 CFR 111.260(b)].
c. The date and time of maintenance, cleaning and sanitizing of equipment used in producing the batch or a cross reference to the records [21 CFR 111.260(c)].
d. The identity and weight of each material used [21 CFR 111.260(e)].
e. A statement of the actual yield and percentage of theoretical yield at appropriate phases of processing [21 CFR 111.260(f)].
f. The actual results which were obtained during the monitoring of operations [21 CFR 111.260(g)].
g. The results of any testing or examination performed during the batch production, or a cross-reference to such results [21 CFR 111.260(h)].
h. Documentation that the finished dietary supplement meets specifications established in accordance with § 111.70(e) and (g) [21 CFR 111.260(i)].
i. Documentation of the manufacture of the batch at the time of performance [21 CFR 111.260(j)].
o The date on which each step of the master manufacturing record was performed as required by 21 CFR 111.260(j)(1).
o The initials of the persons performing each step as required by 21 CFR 111.260(j)(2) including;
- 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 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).
- 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).
j. Documentation at the time of performance of packaging and labeling operations [21 CFR 111.260(k)].
o The unique identifier that you assigned to packaging and labels used, the quantity of the packaging and labels used, and, when label reconciliation is required, reconciliation of any discrepancies between issuance and use of labels as required by 21 CFR 111.260(k)(1).
o An actual or representative label, or cross-reference to the physical location of the actual or representative label specified in the master manufacturing record as required by 21 CFR 111.260(k)(2).
o The results of any tests or examinations conducted of packaged and labeled dietary supplements (including repackaged or relabeled dietary supplements), or a cross-reference to the physical location of such results as required by 21 CFR 111.260(k)(3).
k. Documentation at the time of performance of quality control personnel review of any monitoring operations [21 CFR 111.260(l)(1)(i)].
l. Documentation at the time of performance of any required material review and disposition decision [21 CFR 111.260(m)].
We have reviewed your response, dated September 5, 2012, and found it to be inadequate. You have submitted a SOP but you failed to include an example of the document that will be maintained as your firm’s batch production record that consists of all the required information.
- Your firm did not establish and follow written procedures for calibration of instruments and controls used in manufacturing or testing of components or dietary supplements [21 CFR § 111.25(a)]. Specifically, your firm does not have procedures for the calibration, maintenance, and control of equipment used in to manufacture your dietary supplements.
Misbranding of Dietary Supplements
Your Duzoxin Secret to Slim, Punishment Nutrition and Whey Protein Isolate products are misbranded within the meaning of 403(y) of the Act [21 U.S.C. § 343(y)] because the labels fail to include a domestic address or domestic phone number through which the responsible person (as described in section 761 [21 U.S.C. 379aa-1]) may receive a report of a serious adverse event with such dietary supplements. “Domestic address or domestic phone number” means a complete address or phone number. The labels for these three products do not include complete addresses or phone numbers.
This letter may not list all the violations at your facility. You are responsible for ensuring that your facility operates in compliance with the Act and all applicable FDA regulations, including the CGMP regulation for dietary supplements. We may take further action if you do not promptly correct these violations. For instance, we may take further action to seize your product(s) and/or enjoin your firm from operating.
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.
In addition to the violations listed above, we have the following comment:
- Your firm did not maintain separate or defined areas of adequate size or other control systems to prevent mixups or contamination of components, dietary supplements, or contact surfaces, with microorganisms, chemicals, filth, or other extraneous material [21 CFR 111.20(c)]. Specifically, it was observed that in your finished product warehouse, pallets of whey protein, boxes, containers, and closures were not labeled for identity and disposition. In the raw material warehouse, there was co-mingling of quarantine and raw and accepted materials. We have reviewed your response, dated September 5, 2012 and found it to be reasonably adequate; however you do not address how you will maintain your components in separate or defined areas to prevent mixups or contamination. We will review your proposed corrective action during the next inspection of your firm.
Please respond in writing within fifteen (15) working days from your receipt of this letter. Your response should outline the specific steps you are taking to correct these violations, and include any documentation necessary to show that correction has been achieved. 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.
If you have any questions regarding this letter, please contact Dr. Raymond W. Brullo, Compliance Officer, at (949) 608-2918 or email@example.com. Include the FEI Number 3007387060 on all correspondence.
Your written reply should be sent to:
Director, Compliance Branch
US Food & Drug Administration
Irvine, CA 92612-2446
Alonza E. Cruse, Director
Los Angeles District
cc: Patrick Kennelly, Acting Branch Chief
Food and Drug Branch
California Department of Public Health
1500 Capitol Ave. ~ MS 7602
P.O. Box 997413
Sacramento, CA 95899-7413