| Public Health Service Food and Drug Administration |
New York District |
Department of Health and Human Services
June 24, 2011
WARNING LETTER NYK-2011-24
VIA UPS
Mr. Ankur J. Shah, President
Velocity Pharma LLC
226B Sherwood Avenue
Farmingdale, NY 11735
Dear Mr. Ankur:
The U.S. Food and Drug Administration (FDA) inspected your dietary supplement contract manufacturing and packaging facility, located at 226B Sherwood Avenue, Farmingdale, New York on November 1, 3, 4, 5,10 & 12, 2010, 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 regulation, 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 regulation 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 violations:
1. Your firm 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 plan meet product specifications for identity, purity, strength, and composition, as required in 21 CFR 111.75(c).
• Specifically, you did not provide adequate documentation of your basis for determining that your finished Chaser Plus tablets (lot nos. 10036, 10033, 10040 and 10042), Nerve Food tablets (lot nos. 10041 and 10039), Gas Free Activated Charcoal tablets (lot nos. 10038), SOLO Slim capsules Extra Strength (lot nos. 10029), SOLO Slim capsules Regular Strength (lot nos. 10031 and 10032), and Prost-Xtra Plus capsules (lot no. 10035) meet the specifications for identity, purity, strength and composition.
2. Your firm 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 to verify the identity of the dietary ingredients used to manufacture the following dietary supplements: Chaser Plus tablets (lot nos. 10036,10033,10040 and 10042), Nerve Food tablets (lot nos. 10041 and 10039), Gas Free Activated Charcoal tablets (lot no. 10038), SOLO Slim capsules Extra Strength (lot no. 10029), SOLO Slim capsules Regular Strength (lot nos. 10031 and 10032), and Prost-Xtra Plus capsules (lot nos. 10035).
3. Your firm did not conduct a visual identification of the containers and closures, and review the supplier's invoice, guarantee, or certification to determine whether the packaging specifications are met, as required in 21 CFR 111.75(f).
• Specifically, you did not provide documentation of the results of any tests or examinations conducted on the packaging components (bottles and caps), to ensure that the packaging was consistent with your purchase order. Your firm is required to make and keep such documentation under 21 CFR 111.180(b)(3)(C).
4. Your firm did not identify each unique lot within each unique shipment of packaging and labels in a manner that allows you to trace the lot to the supplier, the date received, the name of the packaging and label, the status of the packaging and label; and to the dietary supplement that you distributed, as required in 21 CFR 111.160(d)(1).
• Specifically, you did not assign unique lot numbers to the bottles and caps for your SOLO Slim capsules (lot nos. 10029, 10030, 10031, 10032 and 10034) and Gas Free + Capsules (lot no. 10038), you could not trace back the assigned bottles and caps to a specific incoming batch in order to confirm that an inspection was conducted on these components prior to their use.
5. Your firm's batch production record did not include documentation, at the time of performance of the manufacture of the batch, including the date on which each step of the master manufacturing record (MMR) was performed and the initials of the persons responsible for performing each step, as required in 21 CFR 111.260(j)(1) and (2).
• Specifically, you did not document the date on which each manufacturing step was performed and the initials of the persons responsible for performing each step at the time of the manufacture of the batch. Instead, you provided a blank Master Formula sheet, which only lists the ingredients and specifications for manufacturing your Chaser Plus capsules formulated with calcium carbonate (lot no. 100360).
6. Your firm did not make and keep records of the following:
• Any material review and disposition on a returned dietary supplement, as required in 21 CFR 111.535(b)(2). Specifically, your firm did not have documentation that any material review and disposition decision was made for the Nerve Food iron tablets (lot no. 10041), returned to the contract film coater for re-coating on 10/20/2010.
• Written procedures for how your firm will receive, store, salvage and investigate returned dietary supplements, as required in 21 CFR 111.535(b)(1). Specifically, your firm did not have documentation that any testing and/or investigation was performed on the Nerve Food iron tablets (lot no. 10041), which were returned to the contract film coater for re-coating on 10/20/2010.
• The reevaluation by quality control personnel of any dietary supplement that is reprocessed and the determination by quality control personnel of whether the reprocessed dietary supplement meets product specifications, as required in 21 CFR 111.535(b)(4). Specifically, your firm did not have documentation that the Nerve Food iron tablets (lot no. 10041), which were returned to the contract film coater for re-coating on 10/20/2010, were re-evaluated by your firm's quality control unit to determine if they met product specifications.
• The results of any testing or examination conducted to determine compliance with product specifications established under 111.70(e), as required in 21 CFR 111.535(b)(3). Specifically, your firm did not have documentation that the two batches of Chaser Plus tablets (lot nos. 10026 & 10033) formulated with calcium carbonate, which were returned to your facility because the tablets were too soft, were re-tested to determine if the product was in compliance with the specifications you established for hardness and thickness
7. Your firm did not make and keep written receiving records (including records such as certificates of analysis, suppliers' invoices, and suppliers' guarantees) for components, packaging, labels, and products that you receive for packaging or labeling as a dietary supplement, as required in 21 CFR 111.180(a) and (b)(2).
• Specifically, there was no record to show receipt, examination and approval to release packaging and labeling components prior to use for Shark Cartilage (lot no. 39170), Calcium Magnesium (lot no. 390419), Fat Burner (lot no. 392980), Ginkgo Biloba (lot no. 3920101), and Lecithin (lot no. 380795).
8. Your firm's batch record did not include a unique identifier that you assigned to each component, packaging, and label used, as required in 21 CFR 111.260(d).
• Specifically, the batch record for Gas Free+ Capsule (lot no. 10038) did not include the lot number or unique identifier that was assigned to each component used in the manufacturing of this dietary supplement.
9. Your firm's MMR did not include written instructions detailing specific actions necessary to perform and verify points, steps, or stages in the manufacturing process where control is necessary to ensure the quality of the dietary supplement, as required in 21 CFR 111.210(h)(3).
• Specifically, your written manufacturing instructions for Chaser Plus Tablets (lot no. 10036) (formulated with Di-Calcium Phosphate and Stearic acid) blended on 9/1/2010, 9/7/2010, 9/9/2010, and 9/14/2010 required the addition of Stearic Acid & Magnesium Stearate filtered through a 60 or 40 mesh screen, followed by a mixing process in process step #5, but did not include the precise mix time required. This record showed "mix for _ minutes" with no specified minutes entered in the blank space.
10. Your firm did not take the necessary precautions during the manufacture of a dietary supplement to prevent contamination of dietary supplements, as required in 21 CFR 111.365.
• Specifically, on 11/1/2010 a review of your tablet compressor revealed that the equipment was not cleaned. The tablet compressor had residual dust powder around the shoot where tablets were discharged.
11. Your firm did not make and keep records for the equipment and utensils that you use in manufacturing and testing a component or dietary supplement, as required in 21 CFR 111.35(a).
• Specifically, you did not make and keep written records of calibrations, inspections, or checks of automated, mechanical, and electrical equipment for the following pieces of equipment: Toledo 4g & 20 kg scales; Ultra Tech Stainless Steel Digital Thickness gauge; 250 kg Algen scale, and Vander Kamp 1000 Tablet Hardness Tester (serial #71010483A).
12. Your firm did not keep written records as required for one year past the shelf life date, if the 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.
• Specifically, you could not provide the Master Formulation for Chaser Plus capsules formulated with calcium carbonate (lot no. 100360) upon request.
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.
We also have the following comments:
• A review of your standard operating procedures (SOPs) revealed that you did not establish a written procedure for your holding and distributing operations. Manufacturers are required to establish procedures for holding and distributing operations, under 21 CFR 111.453.
• You did not have temperature and humidity recording devices installed in your warehouse, as required by your SOP# 1.2 (Monitoring of Temperature & Humidity). Manufacturers are required to hold dietary supplements under appropriate conditions of temperature, humidity, or light so that their identity, purity, strength, and composition are not affected, under 21 CFR 111.455(a).
• For labels issued for SOLO Slim capsules and Gas Free + capsules, you did not maintain a record to show when labels were received. Manufacturers are required to document the date that the components, packaging, labels, or products for packaging or labeling as a dietary supplement were received, under 21 CFR 111.180(b)(3)(ii)(A).
• The following equipment was not qualified prior to use: blenders, the encapsulation machine, the tablet counter, the bottle overwrap, inner lid, and the neck band sealer installed on the packaging line. Manufacturers are required to determine the suitability of the automated, mechanical, or electrical equipment by ensuring that the equipment is capable of operating satisfactorily within the
operating limits required by the process under 21 CFR 111.30(b).
We received your written response to the FDA Form 483, which was dated January 18, 2011 and received on January 20, 2011. We do not address that response because it arrived more than 15 working days after the close of the inspection. Consistent with FDA's federal register notice of August 11, 2009 announcing its program to facilitate the timely issuance of warning letters (74 FR 40211-12), FDA will evaluate your December 18, 2011 response along with any response to this warning letter.
You should 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. 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.
Please send your reply 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
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