- Raphah, Inc.
- Issuing Office:
- New Jersey District Office
| || |
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
| ||New Jersey District Office|
Waterview Corporate Center
10 Waterview Blvd. 3rd Floor
Parsippany, New Jersey 07054
Telephone: (973) 331-4900
FAX: (973) 331-4969
February 26, 2016
VIA UNITED PARCEL SERVICE
Mr. Daniel Jang, President
PO Box 7166
North Brunswick, New Jersey 08902
Dear Mr. Jang:
On September 17, 2015 through September 30, 2015, the U.S. Food and Drug Administration (FDA) conducted an inspection of your dietary supplement manufacturing facility located at 12C Jules Lane, New Brunswick, New Jersey. Our inspection revealed a number of significant violations of 21 CFR Part 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 FD&C Act) [21 U.S.C. § 342(g)(1)] in that they have been prepared, packed or held under conditions that do not meet the current good manufacturing practice regulations for dietary supplements found under 21 CFR Part 111. You may find the FD&C Act and the Code of Federal Regulations (CFR) through links on FDA’s home page at www.fda.gov
. These violations were listed on the Inspectional Observations form (FDA 483) issued to you at the close of the inspection on September 30, 2015.
Adulterated Dietary Supplements
1. Your firm failed to establish required specifications for points, steps, or stages in the manufacturing process where control is necessary to ensure the quality of the dietary supplement and that the dietary supplement is packaged and labeled as specified in the master manufacturing record, as required by 21 CFR 111.70(a). You told our investigator that your firm only established in-process specifications for weight, hardness and thickness. For example, the dietary supplements products Bioenergy Ca+P tablets 90 count bottle and Bioenergy C 1000mg tablets, 90 count bottle did not have product specifications.
- You failed to establish specifications for each component that you use in the manufacture of a dietary supplement, as required by 21 CFR 111.70(b).
- You failed to establish in-process specifications for any point, step, or stage in the master manufacturing record where control is necessary to help ensure that specifications are met, as required by 21 CFR 111.70(c).
- You failed to establish specifications for dietary supplement labels and for packaging that may come in contact with dietary supplements, as required by 21 CFR 111.70(d).
- You failed to establish product specifications for the identity, purity, strength, and composition of the finished batch of the dietary supplement, and for limits on those types of contamination that may adulterate, or that may lead to adulteration of, the finished batch of the dietary supplement, as required by 21 CFR 111.70(e).
- You failed to establish specifications for the packaging and labeling of the finished packaged and labeled dietary supplements, as required by 21 CFR 111.70(g).
Once you have established the above specifications, you must determine whether the specifications have been met as required by 21 CFR 111.73 and make and keep records in accordance with 111.95(b).
2. You failed to collect representative samples of a subset of finished batches of dietary supplements that you manufactured before releasing for distribution to verify that the finished batch of dietary supplement meets established product specifications as required by 21 CFR 111.80(c). Specifically, you failed to establish finished product specifications (21 CFR 111.70(e)) and did not collect the required samples before distribution to verify that the finished batches of Bioenergy Ca+P tablets 90 count bottle and Bioenergy C 1000mg tablets, 90 count bottle, or your other products, met product specifications established under § 111.70(e), and as applicable, § 111.70(a). You informed our inspector that the firm did not have a written procedure for collecting representative samples and that that the firm did not collect any samples before releasing products. You also told our inspector that you did not establish specifications for finished products. We note that, as required by 21 CFR 111.123(b)(2), the quality control personnel must not approve and release for distribution any batch of dietary supplement that does not meet all product specifications established under § 111.70(e).
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). In addition, we note that an MMR must include certain information, as specified in 21 CFR 111.210. Specifically, you informed our investigator that you were unaware of MMR (master manufacturing records) requirements for manufacturing dietary supplements and did not have written master manufacturing records for your products. You supplied our inspector with copies of product formulations and procedures; however, review of these documents revealed that the formulas and batch sizes did not match batch records for the products that your firm has manufactured since April 2014. For example, Bioenergy Ca+P tablets, 90 count bottle, manufactured on 5/20/2014 and Bioenergy C 1000mg tablets, 90 count bottle, manufactured on 5/28/2014.
4. Your firm’s batch production records (BPR) were inadequate because they did not include complete information relating to the production and control of each batch and the requirements to be included in a batch record, as required by 21 CFR 111.255(b) and 111.260. For example, your firm’s BPR for your Bioenergy Ca +P tablets 90 count bottle and Bioenergy C 1000mg tablets, 90 count bottle dietary supplements did not include the following required information:
- The batch, lot, or control number, as required by 21 CFR 111.260(a);
- The date and time of the maintenance, cleaning, and sanitizing of 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, as required by 21 CFR 111.260(c);
- Documentation that the finished dietary supplement meets specifications established in accordance with § 111.70(e) and (g), as required by 21 CFR 111.260(i);
- The initials of the person responsible for weighing or measuring of each component used in a batch [21 CFR 111.260(j)(2)(i)];
- The initials of the person responsible for verifying the weight or measure of each component used in the batch [21 CFR 111.260(j)(2)(ii)];
- The initials of the person responsible for adding the component to the batch [21 CFR 111.260(j)(2)(iii)];
- The initials of the person responsible for verifying the addition of components into a batch [21 CFR 111.260(j)(2)(iv)]; and
- Documentation at the time of performance that quality control personnel review of any monitoring operations, as required by 21 CFR 111.260(l)(1)(i).
5. You failed to conduct at least one appropriate test or examination to verify the identity of any component that is a dietary ingredient prior to its use, as required by 21 CFR 111.75(a)(1)(i). Specifically, during our inspection, you informed our investigator that you do not conduct testing to verify the identity of your dietary ingredients. For example, you did not conduct identity testing for the following dietary ingredients you use in the manufacture of your dietary supplement products:
- Bioenergy Ca+P tablets (b)(4)
- Bioenergy C 1000 mg (b)(4)
You must establish an identity specification for each component that you use in the manufacture of a dietary supplement, as required by 21 CFR 111.70(b)(1), and you must ensure that the tests and examinations that you use to determine whether the specifications are met are appropriate, scientifically valid methods, as required by 21 CFR 111.75(h)(1).
6. You failed to establish and follow written procedures for the responsibilities of the quality control operations, including written procedures for conducting a material review and making a disposition decision, and for approving or rejecting any reprocessing, as required by 21 CFR 111.103. Specifically, you verbally confirmed to our investigator that you have not established any written procedures for your firm’s quality control operations. Moreover, our investigator observed that records, including but not limited to, batch records and packaging records, do not have a QC review signature on them, as required by 21 CFR 111.140(b)(2). Quality control operations must include reviewing and approving all records for packaging and labeling operations, under 111.127(c). Please note that under 21 CFR 111.123(b)(2), quality control personnel must not approve or release for distribution any batch of dietary supplement that does not meet all product specifications.
7. Your firm failed to hold dietary supplement components and in-process materials under conditions that would prevent a mix-up, contamination or deterioration of product, as required by 21 CFR 111.455(c). Our investigator observed dietary supplement ingredients and in-process materials being stored in various locations throughout your facility that that could lead to a mix-up or contamination of the products. Specifically,
- Several drums of in-process dietary supplements were observed with multiple handwritten markings on the drums making it difficult to accurately identify the contents.
- A drum of in-process dietary supplement (marked "7/10/15 Super V+M") was observed without a lid.
- Drums of in-process dietary supplements were stored with old packages of raw materials and finished product that was designated to be disposed of.
- Review of your dietary ingredient storage area revealed an unmarked bag of product, which you identified as Vitamin E that had been removed from its original packaging.
- A plastic drum labeled "SUPREME FRUIT PUNCH" with a white stick-on label that read "MAGNESIUM" was observed stored with the dietary ingredients. You identified this drum as magnesium tablets and stated that it was old product that needed to be disposed of.
8. You failed to establish and follow written procedures for holding and distributing operations, as required by 21 CFR 111.453. You indicated to our investigator that no written procedures have been developed for holding and distributing operations. Specifically, you have not established written procedures detailing the required operations to conduct when holding and distributing dietary supplement products, including, but not limited to, the following:
- Holding reserve samples of dietary supplements in a manner that protects against contamination and deterioration [21 CFR 111.465(a)], including:
- Holding reserve samples of dietary supplements under conditions consistent with product labels or, if no storage conditions are recommended on the label, under ordinary storage conditions [21 CFR 111.465(a)(1)];
- Using the same container-closure system in which the packaged and labeled dietary supplement is distributed [21 CFR 111.465(a)(2)]; and
- Retaining reserve samples for 1 year past the shelf life date (if shelf life dating is used), or for 2 years from the date of distribution of the last batch of dietary supplements associated with the reserve samples, for use in appropriate investigations [21 CFR 111.465(b)].
Your firm did not establish and follow written procedures for the calibration of instruments and controls used in manufacturing or testing of components or dietary supplements [21 CFR § 111.25(a)]. Our inspector requested to review the firm’s procedure and records for calibration and maintenance of equipment used in the dietary supplement manufacturing process and you informed our inspector that your firm did not have written procedures and was not conducting routine calibrations of its equipment. You stated that the firm does conduct routine maintenance of the equipment, but does not maintain records of these actions. Specifically, your firm does not have written procedures for the calibration, maintenance, and control of equipment used in the manufacture of your dietary supplements (i.e., V-Blender (S), Tableting M/C, DC-16 (Gold), Tableting M/C, Silver, Tableting M/C, Blue, Counting M/C (S), Labeling M/C, Air Compressor, and Tablet Deduster (Vector)). Further, under 21 CFR 111.35(b)(1), a manufacturer must make and keep written procedures for calibrating instruments and controls; calibrating, inspecting, and checking equipment, and maintaining, cleaning, and sanitizing equipment, utensils, and other contact surfaces.
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 violations cited in this letter. Failure to promptly correct the violations specified above may result in enforcement action without further notice, including, without limitation, seizure or injunction.
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 non-compliance 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). For a domestic facility, 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.
You should notify this office in writing within fifteen (15) working days from your receipt of this letter, of the specific steps you have taken to correct the noted violations, including an explanation of each step taken to prevent their recurrence. In your response, include documentation of your corrective actions or steps towards long term corrective actions. If you cannot complete all corrective actions before you respond, you should explain the reason for your delay and state when you will correct the remaining deficiencies.
Your response should be sent to the following address: U.S. Food and Drug Administration, 10 Waterview Blvd., Parsippany, 3rd Floor, New Jersey 07054. If you should have any questions regarding any issue in this letter, please contact Andrew Ciaccia, Compliance Officer.
Craig W. Swanson
Acting District Director
New Jersey District Office