Primarch Manufacturing, Inc. 3/5/13
| || |
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
| ||Los Angeles District|
Irvine, CA 92612-2506
VIA UNITED PARCEL SERVICE
March 5, 2013
Mr. Douglas A. Smith, President
Primarch Manufacturing, Inc.
3919 Oceanic Dr., Ste 703
Oceanside, CA 92056-5856
Dear Mr. Smith:
The U.S. Food and Drug Administration (FDA) inspected your dietary supplement manufacturing facility, located at 3919 Oceanic Dr., Ste 703, Oceanside, CA, on August 22 through August 24, 2012. The inspection revealed significant violations of the Current Good Manufacturing Practice (CGMP) regulations for dietary supplements, Title 21, Code of Federal Regulations, 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 they have been prepared, packed, or held under conditions that do not meet the CGMP requirements for dietary supplements. Our investigator’s observations were noted on form FDA 483, Inspectional Observations, which was issued to you on August 24, 2012. You may find the Act and FDA regulations through links in FDA's home page at http://www.fda.gov.
Your significant violations are as follows:
1. You failed to establish the following specifications required by 21 CFR 111.70:
- Identity specifications for each component that you use in the manufacture of a dietary supplement [21 CFR 111.70(b)(1)];
- Component specifications, for each component that you use in the manufacture of a dietary supplement, that are necessary to ensure that specifications of the purity, strength and composition of dietary supplements manufactured using the components are met [21 CFR 111.70(b)(2)];
- Establishing limits on those types of contamination that may adulterate, or may lead to adulteration of the finished batch of the dietary supplements to ensure quality of the dietary supplements [21 CFR 111.70(b)(3)];
- Labeling and packaging specifications for your dietary supplement [21 CFR 111.70(d)];
- 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 [21 CFR 111.70(e)];
- Packaging and labeling specifications to ensure that you use the specified packaging and that you applied the specified label [21 CFR 111.70(g)].
Specifically, you have not established any specifications for any of the products that you manufacture.
We have reviewed your response to the FDA 483 dated September 10, 2012. Your response includes SOPs that you have developed to establish specifications. Your response is inadequate because it does not include any specifications that you established using these SOPs.
2. You failed to conduct at least one appropriate test or examination to verify the identity of a component that is a dietary ingredient, prior to its use, as required by 21 CFR 111.75(a)(1)(i). Specifically, you confirmed to our investigator that you did not conduct any tests for any dietary ingredients used in the manufacture of your product NO Holds N-O Fruit Punch, Lot (b)(4). You are subject to the requirement 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 this requirement. Your firm has not petitioned FDA for such an exemption.
We have reviewed your response to the FDA 483 dated September 10, 2012. Your response includes a SOP for testing raw materials, components, and products (QA 5810). Your response is inadequate because you failed to provide any documentation that would allow us to evaluate whether you are now performing the testing or examination that is required to verify the identity of components that are dietary ingredients under 21 CFR 111.75(a)(1)(i).
3. You failed to prepare and follow a written master manufacturing (MMR) record for each unique formulation of dietary supplement 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. Specifically, you did not have MMRs for each of the unique dietary supplements that you manufacture.
Once you create MMRs, you must identify 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 MMR [21 CFR 111.205(b)(1)]. You also must establish controls and procedures to ensure that each batch of dietary supplement that you manufacture meets the specifications identified [21 CFR 111.205(b)(2)]. In addition, you must make and keep MMRs in accordance with the recordkeeping regulations at 21 CFR 111.605 and 21 CFR 111.610 [21 CFR 111.205(c)].
You informed our investigator that you create new “manufacturing batch records” for every batch order received. These manufacturing batch records are not MMRs. MMRs function as a written procedure for the production of the batch. A batch is prepared by following the written instructions provided in the MMR. However, we note that if you intend to use your manufacturing batch records to create MMRs, the MMRs must include the elements required by 21 CFR 111.210. For example, the manufacturing batch record for your product NO Holds N-O Fruit Punch fails to include the following information required by 21 CFR 111.210:
- The identity and weight or measure of each dietary ingredient that will be declared on the Supplement Facts label and the identity of each ingredient that will be declared on the ingredients list of the dietary supplements [21 CFR 111.210(d)].
- Specifications for each point, step, or stage 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 MMR [21 CFR 111.210(h)(1)].
- Procedures for sampling and a cross-reference to procedures for tests or examinations [21 CFR 111.210(h)(2)].
- Corrective action plans for use when a specification is not met [21 CFR 111.210(h)(5)].
We have reviewed your response to the FDA 483 dated September 10, 2012 and determined it to be inadequate. You provided a number of SOPs for the creation of MMRs and master formulation records. However, you did not provide any completed MMRs to demonstrate that you are now preparing and following a written MMR for each unique formulation that you manufacture.
4. You failed to include required information in your batch production record (BPR) for your No Holds N-O Fruit Punch (Lot (b)(4)) dietary supplement product, as required by 21 CFR 111.260. Specifically, your BPR failed to include the following information:
- 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)];
- An actual or representative label, or a cross-reference to the physical location of the actual or representative label specified in the MMR [21 CFR 111.260(k)(2)].
We have reviewed your response to the FDA 483 dated September 10, 2012. You submitted SOPs to address the creation of batch records for each batch of dietary supplement that you manufacture. Your response is inadequate because you did not submit examples of actual batch records to demonstrate that the violations noted have been corrected.
5. You failed to collect and hold reserve samples of each lot of packaged and labeled dietary supplements that you distribute in the same container-closure system in which the packaged and labeled dietary supplement is distributed, or if distributing dietary supplements to be packaged and labeled, using a container-closure system that provides essentially the same characteristics to protect against contamination or deterioration as the one in which it is distributed for packaging and labeling elsewhere, as required by 21 CFR 111.83(b)(1). Specifically, your reserve samples collected for dietary supplement batches that you manufactured were held in plastic bags.
We have reviewed your response to the FDA 483 dated September 10, 2012, and find it inadequate. You submitted SOPs to address the storage of reserve samples, but your SOPs--specifically (b)(4)--do not address the container-closure system to be used to hold retain samples.
The violations cited in this letter are not intended to be an all-inclusive list of violations that exist 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 the violations cited in this letter. Failure to promptly correct these violations may result in legal action without further notice including, without limitation, seizure and injunction. FDA may re-inspect to verify corrective actions have been completed.
Within fifteen (15) working days of receipt of this letter, please notify this office in writing of the specific steps that you have taken to correct the violations described above. Include an explanation of each step being taken to prevent the recurrence of violations and copies of supporting documentation, including revised MMRs and BPRs. 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. Refer to the Unique Identification Number 392911 when replying.
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 noncompliance 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)]. 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.
If you have any questions regarding this letter, please contact Dr. Raymond W. Brullo, Compliance Officer, at (949) 608-2918 or via e-mail to Raymond.Brullo@fda.hhs.gov
Your written reply should be sent to:
Director, Compliance Branch
US Food & Drug Administration
Irvine, CA 92612-2446
Alonza E. Cruse, Director
Los Angeles District
Patrick Kennelly, Acting Branch Chief
California Department of Public Health
Food and Drug Branch
PO Box 997435
1500 Capitol Avenue, MS-7602
Sacramento, CA 95899-7413
Attn: FDA Correspondence