| Public Health Service Food and Drug Administration |
Dallas District |
Department of Health and Human Services
October 24, 2011
2012-DAL-WL-001
WARNING LETTER
UPS OVERNIGHT MAIL
RETURN RECEIPT REQUESTED
Cheryl A. Cahill, President
Precision Formulations, LP
800 W. Sandy Lake Rd., Suite 200
Coppell, Texas 75019
Dear Ms. Cahill:
The U.S. Food and Drug Administration (FDA) inspected your facility located at 800 W. Sandy Lake Road, Suite 200, Coppell, Texas, on May 2-19, 2011. During our inspection, we evaluated the manufacturing of several of your products, including Braz a Vie Acai, (b)(4)(2.5 fl. oz.), (b)(4)(2.5 fl. oz.), (b)(4), and (b)(4). Because you label these products as dietary supplements, we evaluated whether the products were prepared, packed, and held under conditions that comply with the Current Good Manufacturing Practice (CGMP)regulations for dietary supplements in 21 CFR Part 111. However, this letter should not be interpreted to mean that FDA agrees with your characterization of the products or their ingredients.
During the inspection, our investigators found a number of violations of the dietary supplement CGMP regulations. These violations cause your 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 current good manufacturing practice regulations for dietary supplements. These inspectional observations were provided to you on the FDA-483 form issued at the conclusion of our inspection on May 19, 2011.
You can find the Act and FDA regulations through links at FDA's home page at http://www.fda.gov.
The following violations were observed during the inspection:
1. You failed to conduct at least one appropriate test or examination to verify the identity of the dietary ingredient, (b)(4), as required by 21 CFR 111.75(a)(1)(i), for Lot # (b)(4), (b)(4), and (b)(4) prior to using it in the manufacture of Braz a Vie Acai, Lot #(b)(4).
We received your reply to the FDA-483 dated June 10, 2011. Your response is inadequate because the documentation you provided with your response indicates that the samples from the (b)(4) referenced lots of (b)(4) were not submitted to your contract laboratory until 5/3/2011 and the results were not reported until 5/20/2011. According to your Quarantine Release Report, you released Braz a Vie Acai, Lot #(b)(4) on 4/20/2011, which was before the samples of the (b)(4) were submitted for identity testing. Your response only addresses a single lot and fails to indicate whether you have made changes to your procedures that will ensure that all components will be tested to verify identity before use in the manufacture of your dietary supplement products.
2. You failed to establish the specifications required by 21 CFR 111.70. Specifically:
• You failed to establish component specifications, as required by 21 CFR 111.70(b)(2), for the (b)(4), Lot # (b)(4), (b)(4), and (b)(4) that are necessary to ensure that specifications for the purity, strength, and composition of Braz a Vie Acai, Lot #(b)(4), manufactured using these components are met. You told our investigators that you have not established component specifications for purity, strength and composition.
• You failed to establish product specifications for the strength of the finished batch of dietary supplement, as required by 21 CFR 111.70(e). Specifically, you have not established specifications for the strength of the dietary ingredients (b)(4) found in the proprietary blend used in your (b)(4) Lot # (b)(4) and (b)(4) Lot # (b)(4) products. The supplement facts panel for both products declares (b)(4) of the proprietary blend per (b)(4) fluid ounce serving. You told our investigators that you check the finished product against the finished product label declaration. This does not satisfy the requirement to establish specifications for strength of the finished batch of dietary supplement.
In your June 10, 2011 response letter, you stated that MMRs (master manufacturing records) with more detailed specifications are being put together and will be completed by August 31, 2011. Your response is inadequate because you have not provided documentation to indicate that you have established specifications for specific points, steps, or stages in the manufacturing process where control is necessary to ensure the quality of the dietary supplement.
3. You did not prepare a written master manufacturing record (MMR) for each batch size of dietary supplement that you manufacture to ensure uniformity in the finished batch from batch to batch, as required by 21 CFR 111.205(a). Specifically, you manufacture batches of product in various sizes; however, your MMR for (b)(4), Braz a Vie Acai, and (b)(4) are for (b)(4) only.
In your June 10, 2011 response you stated that your MMRs are under review to have additional instructions and specifications added to the manufacturing process. You stated this would be completed by August 31, 2011. Your response is inadequate because you have not indicated that you have developed MMRs for each batch size or forwarded them for our review.
4. Your master manufacturing records (MMRs) for (b)(4), Acai, and (b)(4) do not 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 [21 CFR 111.210(d)]. Specifically, your MMR for (b)(4) fails to declare the identity and weight or measure of several dietary ingredients such as (b)(4) and (b)(4) that are declared on the Supplement Facts label of the dietary supplement.
• 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 finish 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 [21 CFR 111.210(f)]. Specifically, your MMRs for (b)(4), Braz a Vie Acai, and (b)(4) do not contain any of this information.
• A description of packaging and a representative label, or a cross-reference to the physical location of the actual or representative label [21 CFR 111.210(g)]. Specifically, your MMRs for (b)(4) , Braz a Vie Acai, and (b)(4) products do not contain this information.
• Written instructions, including procedures for sampling and a cross-reference to procedures for tests or examinations; 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 and that the dietary supplement is packaged and labeled as specified in the master manufacturing record; and corrective action plans for use when a specification is not met [21 CFR 111.210(h)]. Specifically, your MMRs for (b)(4), Braz a Vie Acai, and (b)(4) products do not contain this information.
In your June 10, 2011 response you stated that your MMRs are under review to have additional instructions and specifications added to the manufacturing process. You stated this would be completed by August 31, 2011. Your response is inadequate because you have not indicated that you have completed your revisions and forwarded these records for our review.
5. Your batch production records (BPRs) for your (b)(4), Braz a Vie Acai and (b)(4) products do not include the following information required by 21 CFR 111.260:
• The unique identifier that you assigned to packaging used [21 CFR 111.260(d)]. Specifically, the BPR for (b)(4), Lot # (b)(4), does not include complete lot number information for bottles used.
• A statement of the actual yield and a statement of the percentage of theoretical yield at appropriate phases of processing [21 CFR 111.260(f)]. Specifically, your BPR for (b)(4), Lot #(b)(4), Braz a Vie Acai, Lot #(b)(4), (b)(4), Lot # (b)(4), and (b)(4), Lot # (b)(4), lack this information.
• Documentation, at the time of performance, of the manufacture of the batch including the initials of the person weighing or measuring each component used in the batch, the initials of the person responsible for verifying the weight or measure of each component used in the batch, the initials of the person responsible for adding the component to the batch, and the initials of the person responsible for verifying the addition of components to the batch [21 CFR 111.260(j)(2)(iv)]. Specifically, the BPR for (b)(4) Lot # (b)(4) is missing this information for the reverse osmosis water and organic green tea leaf components. The BPR for (b)(4) Lot # (b)(4) is missing the initials for the person who added each component. The BPR for (b)(4), Lot # (b)(4), is missing all of the above information for the reverse osmosis water component.
• Documentation at the time of performance that quality control reviewed the BPR for the results of any tests and examinations on the finished batches of dietary supplements [21 CFR 111.260(l)(1)(ii)]. Specifically,
o Your BPR for (b)(4), Lot #(b)(4), indicates on the Quarantine Release Report that it was released on 3/27/2011. However, your records indicate that quality control reviewed the microbiology results on 4/4/2011.
o Your BPR for Braz a Vie Acai, Lot #(b)(4), indicates on the Quarantine Release Report that it was released on 4/20/2011. Your records indicate that microbiology results were not completed until 4/23/2011, although quality control documented having reviewed the record on 4/20/2011.
o Your BPR for (b)(4), Lot # (b)(4), indicates on the Quarantine Release Report that it was released on 3/26/2011. Your records indicate that microbiology results were not completed until 3/29/2011 although quality control documented having reviewed the record on 3/26/2011. In addition, the results of finished product dietary ingredient analyses for (b)(4) were not completed until 4/8/2011.
o Your BPR for (b)(4), Lot # (b)(4), indicates on the Quarantine Release Report that it was released on 2/5/11. Your records indicate that the microbiology results were not completed until 2/8/11, although quality control documented having reviewed the record on 2/5/11. In addition, the results of finished product dietary ingredient analyses for (b)(4) were not completed until 2/14/2011.
You told our investigators that some results are checked and the product is released verbally but that documentation for these dietary supplements can take up to one week before it is completed. In addition, you have a practice to release finished product after you receive an acceptable (b)(4) hour microbiology test result, but do not wait for the completed (b)(4) microbiological result.
In your June 10, 2011 response, you stated that an additional hire was approved that will ensure that Quarantine tags, which include the unique lot number, are applied to all raw materials, packaging, and labels; new MMRs will state where yield data will be available; you stated that you are changing the sequencing that you close out batch production records; you authorized a new hire to give more time for the Lab Manager to put the completed batch records together properly and in sequence; and your SOP for release will be modified to cover more details on microbiological release, early and routine. You also provided the batch ticket from (b)(4) Lot # (b)(4).
This response is inadequate because it does not address how you will ensure that lot numbers are documented in the BPR; the BPR must contain yield data, not a reference in the MMR to where it can be found; and you have not provided your modified SOP or provided details on how your proposed changes will ensure that your BPRs contain documentation at the time of performance that quality control personnel reviewed the results of any tests or examinations. The batch ticket provided does not correspond to the lot numbers referenced above, nor have you explained how you will ensure that this type of error does not occur in the future.
6. You failed to identify each unique lot within each unique shipment of labels in a manner that allows you to trace the lot to the supplier, the date received, the name of the label, the status of the label (e.g. quarantined, approved, or rejected); and to the dietary supplement that you distributed, as required by 21 CFR 111.160(d)(1). Specifically, on your Label Receiving Report dated (b)(4), you documented receiving (b)(4) sleeve labels for your (b)(4) product with an Item Key of (b)(4). This is a general number used for this label regardless of the date the labels are received. There is no information contained in the section for Lot No. In addition, the Quarantine Release Report in your BPR for Braz a Vie Acai Lot # (b)(4) lists the Label # (b)(4). However, this is a general part number, not a unique lot number. It is pre-printed on each label for this product.
In your June 10, 2011 response, you stated that an additional warehouse hire was approved who will assure that the Quarantine tags, which include the unique lot number, are applied to all the components, packaging and labels in the future. You also stated that you are recommending that a small, unique part number and "revision" number be printed on each label supplied by your customer and you will do this on labels you approve in house. We will verify your correction at the time of the next inspection.
7. You failed to control the issuance and use of labels and reconciliation of any issuance and use discrepancies, as required by 21 CFR 111.410(b). Specifically, according to the Precision Formulations Usage Report in the BPR for (b)(4) Lot # (b)(4), (b)(4) labels were used. However, in the notes section the form indicates that only (b)(4) bottles were labeled while (b)(4) bottles were not labeled. The form does not account for the (b)(4) labels that were not used.
Your June 10, 2011 response does not address the discrepancy described above.
This letter is not an all-inclusive list of violations at your facility. It is your responsibility to ensure that your products comply with the Act and FDA's implementing regulations.
Failure to promptly correct the violations specified above may result in enforcement action without further notice. Enforcement action may include seizure of violative products and/or injunction against the manufacturers and distributors of violative products.
We note that your BPR for (b)(4) Lot #(b)(4) indicates bottles should be hot filled at (b)(4) degrees. However, your records show that the (b)(4) temperatures recorded for this batch never reached this temperature. In your June 10, 2011 response, you stated that you have changed your specification to (b)(4), and that the (b)(4) temperature does not correspond to the bottle fill temperature. If the (b)(4) temperature is not a measurement of bottle fill temperature, it is unclear how you monitor the bottle fill temperature and document that your product meets this specification.
Please advise this office in writing within 15 days from your 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. 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.
Please send your reply to the Food and Drug Administration, Attention: Seri L. Essary, Compliance Officer, at the above letterhead address. If you have any questions regarding any issue in this letter, please contact Seri Essary at (214) 253-5335.
Sincerely,
/S/
Reynaldo R. Rodriguez, Jr.
Dallas District Director
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