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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Applied Polymer Systems, Inc. d/b/a APS Pharmaco 9/27/12

  

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

Public Health Service
Food and Drug Administration
 New York District
158-15 Liberty Avenue
Jamaica, NY 11433  

 

September 27, 2012 
 
WARNING LETTER NYK-2012-25
 
VIA UPS
 
 
Mr. Nuka Reddy, President
Applied Polymer Systems Inc.
200 Bangor Street
Lindenhurst, NY 11757-3644
 
 
Dear Mr. Reddy:
 
The U.S. Food and Drug Administration (FDA) inspected your dietary supplement manufacturing facility, located at 200 Bangor Street, Lindenhurst, New York on May 7 through May 14, 2012, and found that you have serious violations of FDA’s Current Good Manufacturing Practice (CGMP) in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements regulations, Title 21, Code of Federal Regulations, Part 111 (21 CFR Part 111). At the conclusion of the inspection, you were issued a Form FDA 483, List of Inspectional Observations, which listed a number of the violations that 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 requirements for dietary supplements. You may find the Act and its implementing regulations through links on FDA’s home page at www.fda.gov.
 
The inspection revealed the following significant violations:
 
1.  You did not conduct at least one appropriate test or examination to verify the identity of any component that is a dietary ingredient prior to use, as required in 21 CFR 111.75(a)(1)(i). Specifically, you did not perform any tests or examinations to verify the identity of any of the dietary ingredients used to manufacture the following finished dietary supplements:  Raspberry Ketone 250 (lot no. 042412), Barley Sensoriay Green (product no. P-513), 28 Super Amino Acids (product no. P-129), South Island Spirulina (product no. P-152), and South Island Blue Green Algae (product no. P-516).
 
Before using a component that is a dietary ingredient, you must conduct at least one appropriate test or examination to verify the identity of any component that is a dietary ingredient, unless you petition FDA under 21 CFR 111.75(a)(1)(ii) and FDA exempts you from such testing. Your firm has not petitioned FDA for such an exemption.
 
2. You did not verify, for the finished batches of your dietary supplements identified below, that either every finished dietary supplement batch or a subset of the finished dietary supplement batches that you identify through a sound statistical sampling plan 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, as required in 21 CFR 111.75(c). Specifically, you did not perform such finished product testing of your Raspberry Ketone 250 (lot no. 042412), Barley Green, (product no. P-513), 28 Super Amino Acids (product no. P-129), South Island Spirulina (product no. P-152), and South Island Blue Green Algae (product no. P-516) products. 
 
3. You did not qualify a supplier of a component by establishing the reliability of the supplier’s certificate of analysis (COA) through confirmation of the results of the supplier’s tests or examinations, as required in 21 CFR 111.75(a)(2)(ii)(A). Specifically, you did not qualify any of your firm’s raw material suppliers by establishing the reliability of the suppliers’ COAs through confirmation of the results of their tests or examinations. 
 
While you must conduct, at minimum, one test or examination to verify the identity of any component that is a dietary ingredient, you may, if desired, rely on a COA for other specifications for those ingredients, and to confirm the identity of other components that are not dietary ingredients. However, you may only rely on a COA if you have met the requirements of 21 CFR 111.75(a)(2)(ii), which include qualifying the supplier.
 
4. You did not prepare and follow a written master manufacturing record (MMR) for each unique formulation of dietary supplement you manufacture, as required in 21 CFR 111.205(a). Specifically, you did not prepare and follow MMRs for the following dietary supplements: Raspberry Ketone 250 (lot no. 042412), Barley Green (product no. P-513), 28 Super Amino Acids (product no. P-129), South Island Spirulina (product no. P-152), and South Island Blue Green Algae (product no. P-516). You stated that you did not have MMRs, and provided our investigator with formulas for the above-listed products; however, these formulas do not meet the requirements for MMRs in 21 CFR 111.210. These formulas only consist of a product name followed by ingredients, weights, and a few hand-written notes.
 
5. You did not prepare a batch production record (BPR) every time you manufactured a batch of dietary supplements, as required in 21 CFR 111.255(a). Specifically, you did not prepare Sensoria BPRs every time you manufactured a batch of Barley Green (product no. 9-513), 28 Super Amino Acids (product no. P-129), South Island Spirulina (product no. P-152), and South Island Blue Green Algae (product no. P-516).
 
6. Your BPR failed to include complete information relating to the production and control of each batch, as required by 21 CFR 111.255(b) and 111.260. Specifically, the BPR for your Raspberry Ketone 250 (lot no. 042412) product only documented the names and weights of components. It did contain the complete information that is required by 21 CFR 111.255(b), and it did not comply with the following specific requirements in 21 CFR 111.260:
 
· Your BPR must include the identity of the equipment and processing lines used in producing the batch [21 CFR 111.260(b)].  
· Your BPR must include the date and time of the maintenance, cleaning, and sanitizing of the equipment and processing lines used in producing the batch, or a cross-reference to records, such as individual equipment logs, where this information is retained [21 CFR 111.260(c)]. 
· Your BPR must include the unique identifier that you assigned to each component, packaging, and label used [21 CFR 111.260(d)].
· Your BPR must include a statement of the actual yield and a statement of the percentage of theoretical yield at appropriate phases of processing [21 CFR 111.260(f)].
· Your BPR must include documentation, at the time of performance, of the manufacture of the batch, including the initials of the person responsible for weighing or measuring each component used in the batch, the initials of the person responsible for verifying the weight or measure of each component used in the batch, the initials of the person responsible for adding the component to the batch, and the initials of the person responsible for verifying the addition of components to the batch [21 CFR 111.260(j)(2)]. 
· Your BPR must include documentation, at the time of performance, of packaging and labeling operations including 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; an actual or representative label, or a cross-reference to the physical location of the actual or representative label specified in the MMR; and the results of any tests or examinations conducted on packaged and labeled dietary supplements (including repackaged or relabeled dietary supplements), or a cross-reference to the physical location of such results [21 CFR 111.260(k)].
· Your BPR must include documentation at the time of performance that quality control personnel reviewed the BPR; approved or rejected any reprocessing or repackaging; approved and released, or rejected, the batch for distribution, including any reprocessed batch; and approved and released, or rejected, the packaged and labeled dietary supplement, including any repackaged or relabeled dietary supplement [21 CFR 111.260(l)]. 
 
7. You did not keep required written records for one year past the shelf life date, if shelf life dating is used, or two years beyond the date of distribution of the last batch of the dietary supplements associated with the records, as required in 21 CFR 111.605(a). Specifically, you did not keep receiving records associated with incoming shipments of components, as required by 21 CFR 111.180(b)(2), and you did not keep records of product distribution, as required by 21 CFR 111.475(b)(2).
 
8. You have not established written procedures for reviewing and investigating product complaints, as required under 21 CFR 111.553. Specifically, when asked for these written procedures, you stated that none had been established yet.
 
9. You failed to calibrate instruments and controls that you use in manufacturing a component or dietary supplement at routine intervals or as otherwise necessary to ensure the accuracy and precision of the instruments or controls, as required under 21 CR 111.27(b)(3). Specifically, your Cardinal 708 series scale used for weighing raw materials has not been calibrated since November 14, 2008.
 
This letter is not intended to be an all-inclusive list of 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. You should take prompt action to correct these violations and prevent their reoccurrence. Failure to promptly correct these violations may result in legal action without further notice, including seizure and injunction.
 
You should notify this office in writing within fifteen (15) working days from your receipt of this letter of the specific steps that you have taken to correct these violations and prevent their recurrence. Your response should include documentation of the corrective actions that you have taken. 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 re-inspection-related costs. A re-inspection 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. Re-inspection-related costs means all expenses, including administrative expenses, incurred in connection with FDA’s arranging, conducting, and evaluating the results of the re-inspection and assessing and collecting the re-inspection fees (21 U.S.C. 379j-31(a)(2)(B)). For a domestic facility, FDA will assess and collect fees for re-inspection-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 re-inspection-related costs.
 
Your written response should be sent to the Food and Drug Administration, Attention: Kristen C. Jackson. If you have questions regarding any issues in this letter, please contact Kristen Jackson at 718-662-5711.
 
Sincerely,
/S/ 
Ronald Pace
District Director

New York District