| Public Health Service Food and Drug Administration |
Waterview Corporate Center |
Department of Health and Human ServicesFebruary 17, 2011
WARNING LETTER
VIA OVERNIGHT MAIL
RETURN RECEIPT REQUESTED
Mr. Surendra Vallabhaneni
Director of Operations
Rasi Laboratories, Inc.
20 Roosevelt Avenue
Somerset, NJ 08873
File # 11-NWJ-10
Dear Mr. Vallabhaneni:
From August 17,2010 to September 3, 2010, the U.S. Food and Drug Administration (FDA) inspected your firm located at 20 Roosevelt Avenue in Somerset, New Jersey. Our investigators documented a number of serious violations from the current Good Manufacturing Practice (CGMP) regulations for Dietary Supplements, Title 21, Code of Federal Regulations (CFR), Part 111 [21 CFR Part 111]. These violations cause your dietary supplement 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 products have been prepared, packed, or held under conditions that do not meet CGMP regulations for dietary supplements. You may find the Act and FDA regulations through links on FDA's home page at http://www.fda.gov.
These observations were presented to you in a FDA-483 at the conclusion of our inspection on September 3, 2010. Based on the inspection, your significant violations are as follows:
1. Your firm failed to determine whether you met established product specifications for identity, purity, strength and composition prior to distribution, to comply with 21 CFR 111.73. Specifically, you failed to verify that your finished dietary supplement batches of at least three different dietary supplement Lots: Melatonin 10mg Capsules lot #007064, Vibrance Multivitamin Tablets lot #007012, and Complete Joint Care tablets lot #006021, met product specifications for identity, purity, strength, and composition, as required by 21 CFR 111.75(c). You distributed these dietary supplements prior to finished product testing being completed for these lots.
Your September 23, 2010 response is inadequate because it offers no intention to correct the violation. You state that you had an agreement with your customer that the customer was to hold product until you completed finished product testing. However, your release of such product prior to the approval and release by the quality control unit for distribution would be in violation of 21 CFR 111.123(a)(8), 111.123(b), 111.77 and not consistent with your own SOP WH002 because you shipped finished product prior to the quality control unit verifying that the finished product specifications established in accordance with 21 CFR 111.70 had been met.
2. Your firm failed to follow written sampling plans for obtaining representative samples to comply with 21 CFR 111.315(b)(1). Specifically, your QualityControl Unit did not follow your sampling procedure as described in SOP QCOl8 for raw material (components), and routinely collected only one sample, while your written standard operating procedure identifies a sample collection by using the square root of (n) + one, where n is the number of containers. Evidence collected by the FDA investigators showed at least five different dietary supplement lots (Dicalcium Phosphate Dihydrate lot #9-10-24, Glucosamine Sulfate Potassium lot #P20100516, Folic Acid lot #100354, Goldenseal Root Powder lot #03222010-1, and Chromium 10% Polynicotinate lot #5581) where only one sample was collected for identity testing regardless of the number of units received.
Your September 23, 2010 response, that you have begun to follow SOP QCO18 and provided documentation of a new entry for number of samples collected, appears to be adequate. We will verify the adequacy of your corrections during the next inspection of your firm.
3. Your firm failed to hold components and dietary supplements under appropriate conditions of temperature, humidity or light so that the identity, purity, strength and composition of the components and dietary supplements were not affected, to comply with 21 CFR 111.455(a). Specifically, our investigators observed the temperature on the thermometer in your raw material warehouse to be 86 degrees Fahrenheit on August 17,2010 at approximately 3:30pm. However, the temperature specification listed in the Temperature and Humidity Logbook for your raw material warehouse is (b)(4) degrees Fahrenheit with a humidity range of (b)(4) percent and the general temperature specification listed in your SOP MAIN001 is (b)(4)degrees with a humidity range of (b)(4) percent. Additionally, temperature and humidity are monitored once daily at one location, which is not a representation of the temperature in all storage conditions throughout the raw material warehouse.
4. Your physical plant did not have equipment that controls temperature and humidity when it is necessary to ensure the quality of the dietary supplement, to comply with 21 CFR 111.20(d)(1)(iv). Specifically, the new finished product warehouse, which is approximately (b)(4) square feet, is not monitored for temperature and humidity, although your firm stores roughly (b)(4) different products in the warehouse that are labeled for storage at room temperature or a controlled room temperature. Per your SOP MAIN001 collected at the time of inspection, the temperature and humidity of all areas at your facility should generally be maintained at (b)(4) degrees Fahrenheit with a humidity range of (b)(4) percent.
Your September 23, 2010 response is inadequate with respect to both Charge 5 and Charge 6 because you have not accounted for the control and monitoring of temperature for both warehouses. The measuring of relative humidity alone does not address the noted violations.
5. Your firm failed to follow written procedures for calibrating, inspecting, and checking automated, mechanical, and electronic equipment, to comply with 21 CFR 111.25(b). Specifically, our investigator noted on August 17, 2010 that the thermometer and hygrometer in the raw material warehouse was out of calibration, having been due for calibration on January 26, 2010. Your current procedure, SOP MAIN001, states "Thermometer and Hygrometer shall be calibrated annually by outside services and verify by Quality Assurance Department."
This letter is not intended to be an all-inclusive list of violations at your facility. It is your responsibility to ensure that your establishment and the products you market are in compliance with all applicable requirements of the Act and FDA regulations.
Failure to promptly correct the violations specified above may result in regulatory action without further notice, including seizure of violative products and/or injunction against the manufacturers and distributors of violative products.
We also note your firm failed to establish and follow written procedures for maintaining, cleaning, and sanitizing all equipment, utensils and any other contact surfaces that are used to manufacture, package, label, or hold components or dietary supplement products, (see 21 CFR 111.25(c)). Specifically, cleaning procedures for several pieces of manufacturing equipment, (b)(4) station (b)(4) tableting machine, (b)(4) Mixer, Fitzmill, V-blender, at your firm did not specify the quantities of cleaning solutions, rinse water, and the sanitizing agent(s) necessary to adequately remove traces of previously manufactured products and/or cleaning agents. Upon review of your Cleaning SOPs (MR044, MR058, MR062, MR068), we found the procedures to be nonspecific and lack the appropriate level of information and instruction to carry out the process effectively. Due to inadequate procedures, the removal of all potentially harmful residue(s) was not being verified by the Quality Control Unit.
We also note your firm had the same granulation process to ensure that the specifications for strength and composition were met for each type of dietary supplement. Specifically, the granulation time of (b)(4) listed in your master manufacturing records for several products, Glucosamine 750, Chondroitin 300, MSM 400 Tablets; Ultimate Man Gold Sustained Release Tablets; and Ultimate Man 50+ ETS Sustained Release Tablets did not appear to be adequate for all of these products. At the time of inspection, your firm had no other control parameters for granulation, such as granule size. You must establish in-process specifications for any point, step, or stage in the master manufacturing record where control is necessary to ensure that specifications for identity, purity, strength and composition of the dietary supplement are met, as required by 21 CFR 111.70(a). In addition, you must provide adequate documentation of your basis for why meeting such specifications, in combination with meeting component specifications, will help ensure that the specifications for identity, purity, strength, and composition are met, as required by 21 CFR 111.70(c)(2). The quality control personnel must review and approved such documentation, as required by 21 CFR 111.70(c)(3). Further, quality control personnel must approve or reject all processes, written procedures, controls, tests and examinations, and deviations from or modifications to them, that may affect the identity, purity, strength, or composition of a dietary supplement (see 21 CFR 111.105(a)). Quality control operations for the master manufacturing record must include reviewing and approving all master manufacturing records and all modifications to the master manufacturing records (see 21 CFR 111.123(a)(1)), as well as reviewing and approving all batch production-related records (see 21.CFR 111.123(a)(2)).
Please notify this office in writing within 15 working days of receipt of this letter of the specific steps you have taken to correct the violations noted above and to ensure that similar violations do not occur in the future. Your response should include any documentation necessary to show that correction has been achieved. If you cannot complete all corrections before you respond, state the reason for the delay and the date by which you will complete the corrections.
Your written response should be addressed to the U.S. Food and Drug Administration, 10 Waterview Blvd., 3rd Floor, Parsippany, New Jersey 07054, Attn: Joseph F. McGinnis R.Ph, Compliance Officer. If you have any questions about this letter, please contact Compliance Officer Joseph F. McGinnis at (973) 331-4905 or e-mail at joseph.mcginnis@fda.hhs.gov.
Sincerely,
/s/
Diana Amador-Toro
District Director
New Jersey District
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