http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2012/ucm313739.htmJune 26, 2012 - WARNING LETTER - CIN-12-290457-25
John Parrillo, Owner
Parrillo Performance
6200 Union Center Boulevard
Fairfield, Ohio 45246
Dear Mr. Parrillo:
The U.S. Food and Drug Administration (FDA) performed an inspection of your dietary supplement manufacturing and re-packing facility located at 6200 Union Center Boulevard, Fairfield, Ohio 45246. Our investigators found a number of violations of 21 CFR Part 111, The Current Good Manufacturing Practice (CGMP) in Manufacturing, Packaging, Labeling or Holding Operations for Dietary Supplements. Your deviations from the Dietary Supplement regulations 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 the dietary supplements have been prepared, packed or held under conditions that do not meet current good manufacturing practice regulations for dietary supplements. These observations were presented to you on our FDA-483, Inspectional Observations, form issued at the conclusion of our inspection on February 29, 2012.
The inspection revealed the following deficiencies:
1. You failed to establish a specification for any point, step, or stage in the manufacturing process where control is necessary to ensure the quality of the dietary supplement in accordance with 21 CFR 111.70(a). Specifically, you failed to establish component specifications for the dietary supplements, 15 different high protein powders and 5 different energy bars that you manufacture to ensure that the products have the claimed amounts stated on the supplement label.
2. Your firm 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). Our investigator found that you did not conduct identity testing on any dietary ingredients used in your finished dietary supplement products, such as (b)(4) in your Graham Cracker Energy Bar product. Before using a component that is a dietary ingredient, you must conduct at least one appropriate test or examination to verify the identity of any component that is a dietary ingredient, unless you have petitioned FDA for an exemption from such testing, consistent with the requirements in 21 CFR 111.75(a)(1)(ii), and FDA has granted such petition. Your firm has not petitioned FDA for such an exemption.
3. Your firm receives certificates of analysis (COA) from your suppliers for dietary supplement components. Specifically, we reviewed your COA for (b)(4). Under 21 CFR 111.75(a)(2), a certificate of analysis may be used to confirm the identity of a component that is not a dietary ingredient and to determine whether applicable component specifications established in accordance with 21 CFR 111.70(b) are met. In order to rely on a certificate of analysis from a supplier of the component, the requirements of section 21 CFR 111.75(a)(2)(ii) must be met. Some of these requirements include qualifying the supplier by establishing the reliability of the supplier's certificate of analysis through confirmation of the results of the supplier's tests or examinations, maintaining documentation of how the supplier was qualified, and periodically reconfirming the supplier's certificate of analysis [21 CFR 111.75(a)(2)(ii)(A),(C), and (D)]. In addition, the certificate of analysis must include a description of the test or examinations methods) used, limits of the test or examinations, and actual results of the tests or examination [21 CFR 111.75(a)(2)(ii)(B)]. Your firm failed to qualify the suppliers of components by establishing the reliability of the suppliers’ COA through confirmation of the results of the suppliers’ tests or examination, as required by 21 CFR 111.75(a)(2)(ii)(A).
4. Your firm failed to implement quality control operations as required by 21 CFR 111.65. In addition, your firm failed to establish 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.
5. Your firm failed to prepare and follow written master manufacturing records (MMR) for each unique formulation of dietary supplements that you manufacture, and for each batch size, to ensure uniformity in the finished batch to batch as required by 21 CFR 111.205(a). Our investigators found that you did not prepare an MMR for any of your products.
6. Your batch production records (BPR) for your “Hi-Protein Powder chocolate flavor” and “Parrillo Protein Bar graham cracker flavor” products do not include complete information relating to the production and control of each batch, as required by 21 CFR 111.255(b) and 21 CFR 111.260. Specifically, your BPR did not include the following required information:
A. The identity of equipment and processing lines used in the producing batch as required by 21 CFR 111.260(b)
B. The date and time of the maintenance, cleaning, and sanitizing of the equipment and processing 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)
C. The unique identifier that you assign to each component (or when applicable, to a product that you receive from a supplier for packaging or labeling as a dietary supplement), packaging, and label used as required by 21 CFR 111.260(d)
D. The actual results obtained during any monitoring operation as required by 21 CFR 111.260(g)
E. The results of any testing or examination performed during the batch production, or a cross-reference to such results as required by 21 CFR 111.260(h)
F. Documentation that the finished dietary supplement meets specifications established in accordance with 21 CFR 111.70(e) and (g) as required by 21 CFR 111.260(i)
G. Documentation at the time of performance, of the manufacture of the batch, as required by 21 CFR 111.260(j) including:
1. The date on which each step of the master manufacturing record was performed as required by 21 CFR 111.260(j)(1).
2. The initials of the persons performing each step as required by 21 CFR 111.260(j)(2) including;
a. The initials of the person responsible for weighing or measuring each component used in the batch as required by 21 CFR 111.260(j)(2)(i).
b. The initials of the person responsible for verifying the weight or measure of each component used in the batch as required by 21 CFR 111.260(j)(2)(ii).
c. The initials of the person responsible for adding the component to the batch as required by 21 CFR 111.260(j)(2)(iii).
d. The initials of the person responsible for verifying the addition of components to the batch as required by 21 CFR 111.260(j)(2)(iv).
H. Documentation at the time of performance, of packaging and labeling operations as required by 21 CFR 111.260(k) including:
1. The unique identifier that you assigned to packaging and labels used, the quantity of the packaging and labels used, and, when label reconciliation is required, reconciliation of any discrepancies between issuance and use of labels as required by 21 CFR 111.260(k)(1).
2. An actual or representative label, or cross-reference to the physical location of the actual or representative label specified in the master manufacturing record as required by 21 CFR 111.260(k)(2).
3. The results of any tests or examinations conducted of packaged and labeled dietary supplements (including repackaged or relabeled dietary supplements), or a cross-reference to the physical location of such results as required by 21 CFR 111.260(k)(3).
I. Documentation, at the time of performance, that quality control personnel as required by 21 CFR 111.260(1):
1. Reviewed the Batch Production Record as required by 21 CFR 111.260(1)(1)
a. Review of any monitoring operation required under Subpart E, Requirement to Establish a Production and Process Control System, as required by 21 CFR 111.260(1)(1)(i)
b. Review of the results of any tests, examinations, including tests and examinations conducted on components, in-process materials, finished batches of dietary supplements, and packaged and labeled dietary supplements as required by 21 CFR 111.260(1)(1)(ii)
2. Approved or rejected any reprocessing or repackaging as required by 21 CFR 111.260 (1)(2)
3. Approved and released, or rejected, the batch for distribution including any reprocessed batch as required by 21 CFR 111.260(1)(3)
4. Approved and released, or rejected, the packaged and labeled dietary supplement, including any repackaged or relabeled dietary supplement as required by 21 CFR 111.260(1)(4)
J. Documentation at the time of performance of any required material review and disposition decision as required by 21 CFR 111.260(m)
K. Documentation at the time of performance of any reprocessing as required by 21 CFR 111.260(n)
7. Your firm failed to establish and follow written procedures for the receipt of packaging, labeling, and product intended to be packaged and/or labeled as a dietary supplement, as required by 21 CFR 111.153. In addition, your firm failed to make and keep the appropriate records for fulfilling the requirements in 21 CFR 111.180.
8. Your firm failed to establish and follow written procedures for product complaints, as required by 21 CFR 111.553. In addition, your firm failed to make and keep the appropriate records for fulfilling the requirements in 21 CFR 111.570.
9. Your firm failed to establish and follow written procedures for when a returned dietary supplement is received, as required by 21 CFR 111.503. In addition, your firm failed to make and keep the appropriate records for fulfilling the requirements in 21 CFR 111.535.
10. Your firm failed to establish and follow written procedures for manufacturing operations, as required by 21 CFR 111.353. In addition, your firm failed to make and keep the appropriate records for fulfilling the requirements in 21 CFR 111.375.
11. Your firm failed to establish and follow written procedures for packaging and labeling operations, as required by 21 CFR 111.403. In addition, your firm failed to make and keep the appropriate records for fulfilling the requirements in 21 CFR 111.430.
12. Your firm failed to establish and follow written procedures for holding and distributing operations, as required by 21 CFR 111.453. In addition, your firm failed to make and keep the appropriate records for fulfilling the requirements in 21 CFR 111.475.
13. Your firm failed to establish and follow written procedures for personnel, including the prevention of microbial contamination from sick or infected personnel, as required by 21 CFR 111.8. Our investigators noted the following practices:
A. An employee manufacturing Graham Cracker Energy Bars reached elbow deep into the mixing bowl, but only washed and sanitized their hands and wrists
B. A different employee reached into the same mixing bowl while wearing a diamond ring
C. Two male employees with facial hair were observed manufacturing without wearing beard-nets.
In addition, your firm failed to make and keep the appropriate records for fulfilling the requirements in 21 CFR 111.14.
14. Your firm failed to establish and follow written procedures for calibrating instruments and controls, inspecting equipment, and cleaning and sanitizing equipment that you use in manufacturing a component or dietary supplement, as required under 21 CFR 111.25. In addition, your firm failed to make and keep the appropriate records for fulfilling the requirements in 21 CFR 111.35.
15. Your firm failed to establish and follow written procedures for cleaning the physical plant and pest control, as required by 21 CFR 111.15. In addition, your firm failed to make and keep the appropriate records for fulfilling the requirements in 21 CFR 111.23
We received your response on March 21, 2012. Your response states you are working on all items step by step and some of them items are already completed. We have reviewed your response and we find it inadequate because you have not provided any documentation to indicate that you have corrected any of the deficiencies observed during your inspection.
The above-identified deviations are not intended to be an all-inclusive list of deficiencies at your dietary supplement manufacturer and re-packer. It is your responsibility to ensure that your firm is in compliance with all requirements of the Act and federal regulations. You should take prompt action to correct the current deviations. Your failure to promptly correct these deviations may result in administrative and/or regulatory action without further notice.
We also note the following:
• Your firm does not retain reserve samples for the required time. During the inspection it was noted that the oldest retain sample date was August 2, 2011 for your “French Vanilla Energy Bars” (lot #21411) product. Reserve samples are required to be retained for one year past the shelf life date (if shelf life dating is used), or for two years from the date of distribution of the last batch of dietary supplements associated with the reserve sample as required by 21 CFR 111.83(b)(2)-(3) and 21 CFR 111.465(b).
Please notify this office in writing within 15 working days of receipt of this letter of the specific steps you have taken or will take to correct the noted violations and to prevent their recurrence. Include documentation of any corrective action you have taken. If corrective action cannot be completed within 15 working days, state the reason for the delay and the time within which the corrections will be completed.
Your response should be sent to: Food and Drug Administration, Attention: Allison C. Hunter, Compliance Officer, 6751 Steger Drive, Cincinnati, OH 45237-3097. If you have questions regarding any issues cited in this letter, please contact Ms. Hunter at 513-679-2700, Extension 2134 or at allison.hunter@fda.hhs.gov.
Sincerely
/s/
Paul J. Teitell
District Director
Cincinnati District Office
