| Public Health Service Food and Drug Administration |
Waterview Corporate Center |
Department of Health and Human ServicesFebruary 9, 2011
WARNING LETTER
CERTIFIED MAIL
RETURN RECEIPT REQUESTED
Mr. Achyut Sahasra, President
Vita Pure, Inc.
410 1st Avenue
Roselle, New Jersey 07203-1047
11-NWJ-07
Dear Mr. Sahasra:
On September 10 through September 23, 2010 the U.S. Food and Drug Administration (FDA) inspected your facility located at 410 1st Avenue Roselle, New Jersey. Your firm manufactures, packages, labels, and holds dietary supplements. Our investigators found a number of serious violations of 21 CFR 111, Current Good Manufacturing Practice (CGMP) in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements.
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. These observations were presented to you in a FDA-483 at the conclusion of our inspection on September 23, 2010.
Deficiencies observed at your facility include:
1. You failed to determine whether established product specifications for purity, strength, and composition of the finished batches of your dietary supplements identified below were met, as required by 21 CFR 111.73. You may verify that these specifications are met by testing or examining every finished batch or a subset of finished batches for each of the dietary supplements you manufacture [21 CFR 111.75(c)]. If you test a subset of finished batches, you must identify the subset using a sound statistical sampling plan [21 CFR 111.75(c)]. You informed us during the inspection that your current practice of testing finished products only occurs upon your customers’ requests. However, our review of your records revealed that you did not conduct any testing to ensure that specifications for purity, strength, and composition were met for the following finished dietary supplements:
a. Calcium 600 W/ Vitamin D3 (200IU) tablets, lots 041056 and 091042
b. Immpower (AHCC 500MG) capsules, lots 061068 and 091041
2. You failed to include in your master manufacturing record (MMR), the following information required by 21 CFR 111.210:
• A complete list of components to be used and an accurate statement of the weight or measure of each component to be used in the production of your Immpower (AHCC 500mg) capsules, as required by 21 CFR 111.210(b) and 21 CFR 111.210(c). Specifically, the capsule ingredients for these products were not listed.
• A statement of theoretical yield of a manufactured dietary supplement expected at each point, step, or stage of the manufacturing process where control is needed to ensure the quality of the dietary supplement, and the expected yield when you finished manufacturing the dietary supplement, including the maximum and minimum percentages of theoretical yield beyond which a deviation investigation of a batch is necessary and material review is conducted and disposition decision is made for Immpower (AHCC 500mg) capsules and Calcium 600 W/ Vitamin D3 (200IU), as required by 21 CFR 111.210(f). Specifically, the MMRs of these products do not include theoretical yields for the weighing, and compression of the manufacturing process.
• A description of packaging and a representative label, or cross-reference to the physical location of the actual or representative label for Immpower (AHCC 500mg) capsules and Calcium 600 W/ Vitamin D3 (200IU), as required by 21 CFR 111.210(g).
• Procedures for sampling in the MMRs for Immpower (AHCC 500mg) capsules and Calcium 600 W/ Vitamin D3 (200IU), as required by 21 CFR 111.210(h)(2).
• The written instructions in your master manufacturing records for the product Immpower (AHCC 500mg) capsules did not include corrective action plans to use when a specification is not met, as required by 21 CFR 111.210(h)(5). Specifically, the encapsulation point, step, or stage of the manufacturing process indicates the following: “[f]ill the hopper with the powder and get the running weight as specified, check for any defects. If capsules are fine, run according to encapsulation specification.” However, your MMR does not include corrective action plans when the encapsulation specification is not met.
3. You failed to prepare and follow a written master manufacturing record (MMR) for each unique formulation of dietary supplement that you manufacture, and for each batch size, to ensure uniformity in the finished batch from batch to batch, as required by 21 CFR 111.205(a). Specifically, your (b)(4) for the product Immunpower (AHCC 500MG) capsules was pre-printed for the specific batch size of (b)(4). However, you modify the batch size by crossing out the (b)(4) and writing in a different batch size of (b)(4) in its place and changing the amount of the AHCC component from (b)(4) kilo.
4. Your batch production records (BPR) did not include complete information relating to the production and control of each batch of your Immpower (AHCC) capsules, Lot #’s 061068 and 091041 and Calcium 600 W/ Vitamin D3(200IU) tablet, Lot #’s 041056 and 091042, as required by 21 CFR 111.255(b). Specifically, your BPR did not include the following required information:
• The identity of equipment used in producing the batch of Immunpower (AHCC) capsules and Calcium 600 W/ Vitamin D3 (200IU) tablets, as required by 21 CFR 111.260(b). Specifically, the batch records do not identify the scale(s) and blender(s) used during production.
• 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 log, where this information is retained, as required by 21 CFR 111.260(c).
• Your firm's batch production records do not include the unique identifier that you assigned to each component, as required by 21 CFR 111.260(d). Specifically, a review of your batch records revealed a lack of a unique identifier listed for the following components:
o Calcium Carbonate granular (Ca 38%), Vitamin D3 (5000,000 IU/gm), Elcema (Cellulose), Vivasol (croscarmellose sodium), Stearic acid, and Sipernat (Silicon dioxide), listed as components in Calcium 600 W/ Vitamin D3(200IU), Batch #’s 041056 and 091042.
o AHCC (Mushroom Root Extract), listed as a component in Immpower (AHCC 500MG), Batch #’s 061068 and 091041.
5. You failed to make and keep written procedures for product complaints, as required by 21 CFR 111.570(b)(1). Specifically, you did not have written procedures for the handling of any complaints regarding the dietary supplement products you manufacture and to adequately investigate complaints and document the findings of an investigation and follow-up.
6. You failed to make and keep documentation in individual equipment logs, of the date of use, maintenance, cleaning, and sanitizing of equipment unless such documentation is kept with the batch record as required by 21 CFR 111.35(b)(2). Specifically, you did not have records of maintenance and cleaning of all equipment used in the manufacturing of your dietary supplements
7. You failed to make and keep documentation of calibration, 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, you did not have records of calibration for the scale(s) used to weigh raw ingredients in the formulation room.
8. You failed to establish and follow written procedures for holding and distributing operations under 21 CFR 111.453. Specifically, you did not establish written procedures in controlling and monitoring the temperatures of your warehouses that store raw materials and finished products.
Your firm has not yet submitted a written response to the FDA-483 observations noted our inspection. The above violations are not intended to be an all-inclusive list of deficiencies at your facility. It is your responsibility to ensure that all of your firm’s products are in compliance with federal laws and regulations. You should take prompt action to correct the violation cited in this letter. Failure to promptly correct the violation may result in legal action without further notice including seizure. You should within fifteen working days of receipt of this letter, please notify this office in writing of the specific steps that you have taken to correct violation including an explanation of each step taken to prevent the recurrence of violations and copies of supporting documentation. If you cannot complete corrective action within fifteen working days, state the reason for the delay and the date by which you will have completed the correction.
Your response should be sent to Compliance Officer, Andrew Ciaccia at the following address: U.S. Food and Drug Administration, 10 Waterview Blvd., Parsippany, New Jersey 07054. If you should have any questions regarding any issue in this letter, please contact Andrew Ciaccia at 973-331-4904.
Sincerely,
/s/
Diana Amador-Toro
District Director
New Jersey District
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