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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Protica, Inc 2/17/12

  

Department of Health and Human Services logoDepartment of Health and Human Services

Public Health Service
Food and Drug Administration
 PHILADELPHIA DISTRICT
900 U.S. Customhouse
2nd and Chestnut Streets
Philadelphia, PA 19106
Telephone: 215-597-4390

 

WARNING LETTER
11-PHI-09
           
                                                                                    February 17, 2012
OVERNIGHT MAIL
RETURN RECEIPT REQUESTED
 
James F. Duffy, President
Protica, Inc.
1002 Macarthur Road
Whitehall, PA 18052
 
Dear Mr. Duffy:
 
The U.S. Food and Drug Administration (FDA) conducted an inspection of your facility, located at 1002 Macarthur Road, Whitehall, PA, from September 29, 2011 through October 6, 2011. The inspection determined that your facility produced acidified protein and energy drinks, acidified protein gelatin snacks and acidified dietary supplements and revealed that you have significant violations from the requirements of the Acidified Foods Current Good Manufacturing Practice regulations, Title 21, Code of Federal Regulations, Parts 114, (21 CFR Part 114) and Part 108, Emergency Permit Control (21 CFR Part 108).
 
As a manufacturer of acidified food products, you are required to comply with the Federal Food, Drug, and Cosmetic Act (the Act) and the federal regulations relating to the processing of acidified food products. These regulations are described in Title 21, Code of Federal Regulations, Part 108, Emergency Permit Control (21 CFR Part 108), and Part 114, Acidified Foods (21 CFR Part 114). The Emergency Permit Control regulations were issued, in part, pursuant to Section 404 of the Act, Emergency Permit Control [21 U.S.C. § 344]. A temporary emergency permit may be required for an acidified food whenever a processor has failed to fulfill the requirements of 21 CFR 108.25, including registration and filing of process information, and the mandatory requirements in 21 CFR Part 114.  In addition, based upon certain criteria in 21 CFR 114, acidified foods may be adulterated within the meaning of section 402(a)(3) of the Act [21 U.S.C. § 342(a)(3)] in that they consist in whole or in part of any filthy, putrid, or decomposed substance, or if they are otherwise unfit for food, or within the meaning of section 402(a)(4) [21 U.S.C. § 342(a)(4)] in that they have been prepared, packed, or held under insanitary conditions whereby they have become contaminated with filth, or whereby they may have been rendered injurious to health. 
 
Further, our inspection revealed serious violations of FDA’s Current Good Manufacturing Practice (CGMP) regulations for Dietary Supplements, Title 21, Code of Federal Regulations (CFR), Part 111 (21 CFR Part 111). These violations cause your Rapid Refuel Dietary Supplement products to be adulterated within the meaning of section 402(g)(1) of 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 requirements for dietary supplements.  You may find the Act and FDA regulations through links on FDA’s home page at http://www.fda.gov.
 
We have received your October 12, 2011, written response to the Form FDA 483, Inspectional Observations, issued to your firm on October 6, 2011. Our comments regarding the adequacy of the actions you described in your written response are detailed after each violation that is noted below.
 
Adulterated Acidified Foods
 
The significant violations of 21 CFR Part 114 and Part 108 are as follows:
 
1.   You failed to provide FDA, after receiving the request in writing, process and procedure information FDA deemed necessary to determine the adequacy of the process, as required by 21 CFR 108.25(c)(3)(ii). Specifically, you failed to provide investigators with scheduled processes for approximately (b)(4) products,   with the exception of one representative product in each of the following four categories: Profect (malic-based protein liquid); Amplified Shooter (malic-based energy liquid); Protein Gem (malic-based protein gelatin); and Sunkist Energy (citric-based energy liquid). Further, there is no scheduled process for any citric-based protein liquid drinks that your firm manufactures.
 
We have reviewed your response dated 10/12/2011. In your response you indicate that you will request your processing authority to provide you scheduled process letters for these products. Your response is inadequate because you did not provide these letters with your response; therefore FDA could not evaluate your proposed correction.  
 
2.   Your firm failed to process each food in conformity with at least the scheduled process filed with FDA, as required by 21 CFR 108.25(c)(3)(i). Specifically, your firm has (b)(4) products/processes filed with FDA, all of which have a critical factor for a (b)(4) fill temperature of (b)(4)F. However, during our inspection our investigator observed that the following products are heated to (b)(4) fill temperatures as follows: Amped Up-2oz. and Fireball-2oz. to (b)(4)F; Healthy Shot-2.5oz. to (b)(4)F; all other 2oz. and 2.5oz. products produced on Line 2 to (b)(4)F; Simplifast 16oz. and Rapid Refuel to (b)(4)F; and Sunkist Energy to (b)(4)F.
 
We have reviewed your response dated 10/12/2011. In your response you indicate that you will request your processing authority to provide process letters for these products which allow for deviations amongst these products using a sliding ph / temperature scale. Your response is inadequate because you did not provide these letters with your response, and a review of FDA’s data base does not indicate that additional processes have been filed; therefore FDA could not evaluate your proposed correction.
 
3.   Your firm failed to ensure that each food is manufactured in accordance with the scheduled process as required by 21 CFR 114.80(a)(1). Specifically, the scheduled process for “Protein Gem” protein gelatin requires a minimum product temperature of (b)(4)F to be held for (b)(4), prior to filling. Our investigator determined that this scheduled process is used by your firm as a representative process for all of your malic-based protein gelatins, to include, Protein Gem, Protein Snack, and Gelatein. This scheduled process was not followed for your Protein Snack, lot (b)(4), 6oz., manufactured on July 14, 2011, in that the initial filling temperature was (b)(4)F and the final filling temperature was (b)(4). In addition, the temperature/hold time preprinted on your manufacturing record (HACCP CCP 1B & 2B for CCP 2B (b)(4)(Line 4), for this lot is (b)(4)F for (b)(4).”
 
Further, the process for “Rapid Refuel” malic-based protein liquid requires a minimum product temperature of (b)(4)F to be held for (b)(4), prior to filling. Our investigator determined that all malic-based protein liquids use the representative scheduled process for “Profect, 3oz”. This scheduled process was not followed for your “Rapid Refuel, 20oz., lot (b)(4) manufactured on September 12, 2011, in that the initial filling temperature was (b)(4)F and the final filling temperature was (b)(4)F. In addition, the temperature/hold time preprinted on your manufacturing record (HACCP CCP 1B & 2B for CCP 2B (b)(4)(Line 3)), for this lot is “(b)(4).”
 
We have reviewed your response dated 10/12/2011. In your response you indicate that you will request your processing authority to provide process letters for these products which denotes one specific “hold time” at the given temperature. Your response is inadequate because you did not provide these letters with your response; therefore FDA could not evaluate your proposed correction.
 
4.   Your firm failed to provide the FDA, before packing any new product, information on the scheduled processes for each acidified food in each container size, as required by 21 CFR 108.25(c)(2). Specifically, your firm has not filed processes for products manufactured in container sizes of 1oz., 2oz., 4oz., 8oz., 10oz., 16oz., and 20oz. You informed our investigator that the (b)(4) processes your firm filed with FDA are representative of each product category as follows: 3oz. containers for malic-based protein liquids, malic-based energy liquids, citric-based protein liquids, and citric-based energy liquids; and 6oz. container for malic-based protein gelatins. We wish to advise you that filing a representative size, for the same product, is not an acceptable practice unless you have determined, through a scientific study that the process results in a safe product. It is important to note that a change in container size may result in varying critical factors, in order to manufacture a product that is not hazardous to health. 
 
We have reviewed your response dated 10/12/2011. In your response you indicate that you will file with the FDA, the specific package size types used under each categorical process. Your response is inadequate because you did not provide any documentation with your response which indicates that you have filed theses processes, and a review of FDA’s data base revealed that additional processes have not been filed.   
 
Adulterated Dietary Supplements
 
The significant violations of 21 CFR Part 111 are as follows:
 
5. Your firm failed to verify that your finished batch of a dietary supplement met product specifications for identity, purity, strength, and composition, as required by 21 CFR 111.75(c). Specifically, you did not verify that these product specifications were met for your dietary supplement, Rapid Refuel 20oz., lot (b)(4) You may verify that these specifications are met by testing or examining every finished batch or a subset of finished batches that you identify through a sound statistical sampling plan [21 CFR 111.75(c)].
 
We have reviewed your response dated October 12, 2011, and found it to be inadequate. Your response did not provide a commitment to ascertain that your products meet product specifications for identity, purity, strength and composition.
 
6. When a dietary supplement failed to meet an established specification, your quality control personnel did not reject the dietary supplement, nor did they approve a treatment, an in-process adjustment, or reprocessing that would ensure the quality of the finished dietary supplement and that the dietary supplement was packaged and labeled as specified in your master manufacturing record (MMR), as required by 21 CFR 111.77(a) and 111.113(b)(2); nor did your firm’s quality control personnel conduct a material review and make a disposition decision when the established specification was not met, as required by 21 CFR 111.113(a)(1).
 
Specifically, your firm's quality control personnel approved the release of the finished batch of your dietary supplement, Rapid Refuel 20oz., lot (b)(4), when the finished product specification for Staphylococcus Aureus of negative was not met. The microbiological lab results of your in-house testing that you provided during the inspection revealed results of (b)(4) CFUs, (b)(4) CFUs, and (b)(4) CFUs on September 13, 14 and 16, 2011, respectively, which were above the specification established for Staphylococcus Aureus, and which contradicted your Certificate of Analysis for this product, which stated that the product was negative for Staphylococcus Aureus.   It is the responsibility of your firm’s quality control personnel to reject dietary supplements that do not meet established specifications unless your quality control personnel approve a treatment, an in-process adjustment, or reprocessing that will ensure the quality of the finished supplement [21 CFR 111.77(a), 111.113(b)(2)], and to conduct a material review and make a disposition decision when an established specification is not met [21 CFR 111.113(a)(1)]. Instead, you continued to re-test the finished product for the microbial specification until (b)(4) test result indicated that the established specification was met.
 
We have reviewed your response dated October 12, 2011, and found it to be inadequate. Your response does not address the observation that you conducted multiple microbiological tests when the initial or consecutive microbiological tests failed.   
 
7. Your firm failed to quarantine components until  quality control personnel had reviewed and approved the results of any tests or examinations conducted on the components, prior to using the components in the manufacture of a dietary supplement, as required by 21 CFR 111.155(c)(2). Specifically, your in-house (b)(4) Spectrometry (b)(4) results for malic acid, supplier batch (b)(4), were not reviewed by quality control personnel. Your firm used this component in the manufacturing of your dietary supplement, Rapid Refuel 20oz., lot (b)(4)
 
We have reviewed your response, and determined it is inadequate. It states that you will establish a documented ingredient release program. However, you did not provide any documentation with your response; therefore, FDA could not evaluate your proposed corrections.   
 
8. Your firm 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, our investigator found that you did not prepare an MMR for your dietary supplement, Rapid Refuel 20oz., lot (b)(4)
 
We have reviewed your response, and determined it is inadequate. It states that you will examine the best method of implementing a master manufacturing record for each SKU and implement. However, you did not provide any documentation with your response; therefore FDA could not evaluate your proposed corrections.  
 
9. In documenting your calibration of instruments and controls that you use in manufacturing or testing a component or dietary supplement, your firm failed to identify the calibration method used, including appropriate limits for accuracy and precision of instruments and controls when calibrating, as required by 21 CFR 111.35(b)(3)(iv). Specifically, you failed to indicate limits and/or tolerances for the pH meter calibration readings relating to pH meter (b)(4). This pH meter was used to test your dietary supplement, Rapid Refuel, 20oz., lot (b)(4). It is imperative that your pH readings are accurate as pH is a critical factor in all of your processes and filings for your products.
 
We have reviewed your response, and determined it is inadequate. It states that you will indicate limits and tolerances on all records documenting instrument calibration data, with subsequent corrective actions for deviation. Further, you state that all affected personnel with be re-trained. However, you did not provide any documentation with your response; therefore FDA could not evaluate your proposed corrections.      
 
10. Your batch production records (BPR) failed to include complete information relating to the production and control of each batch of dietary supplement product you manufacture, as required by 21 CFR 111.255(b).  Specifically, your BPR for your dietary supplement, Rapid Refuel 20oz., lot (b)(4), did not include the following required information:
  • The identity of equipment for processing line 3 to fill the 20 ounce bottles used in producing the batch [21 CFR 111.260(b)];
  • 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 logs, where this information is retained [21 CFR 111.260(c)];
  • A statement of the actual yield [21 CFR 111.260(f)];
  • Documentation, at the time of performance, of the manufacture of the batch, specifically the initials of the person responsible for adding the component to the batch [21 CFR 111.260(j)(2)(iii)].
  • An actual or representative label, or a cross-reference to the physical location of the actual or representative label specified in the master manufacturing record [21 CFR 111.260(k)(2)];
  • Documentation at the time of performance that quality control personnel approved and released, or rejected, the batch for distribution [21 CFR 111.260(l)(3)].
 
This letter is not intended to be an all-inclusive list of violations at your facility. You are responsible for ensuring that your facility operates in compliance with the Act and all applicable regulations, including the Acidified Foods regulations (21 CFR 114), and the Current Good Manufacturing Practice regulations for Dietary Supplements (21 CFR Part 111).
 
You should take prompt action to correct the violations described in this letter and to establish and implement procedures which will prevent them from occurring in the future. Failure to implement lasting corrective action may result in regulatory action being initiated by FDA without further notice, such as seizure, injunction, and/or issuance of an Order of Need to obtain and hold a Temporary Emergency Permit.
 
In addition to the above violations, we also have the following comments:
  • A review of your firms “filed” processes in our FDA data base revealed that the same “process source” letter is referenced for all five processes that you submitted, even though this source letter is specifically for one of the product categories that your firm manufactures. You provided our investigator with this “process source” letter dated January 29, 2010 and informed him that this process is representative of your firm’s acidified citric-based energy liquids filed under SID (b)(4). In addition, you provided our investigator with three other “process source” letters and related product information. Further, your firm filed a process with FDA and during the inspection; you were unable to provide a “process source” letter to our investigator for that product category. As a processor of acidified foods, it would be prudent for your firm to verify all of your filing with FDA, to assure that you provide correct information from your scheduled processes. 
  • For each lot of packaged and labeled dietary supplements that you distribute, your firm must collect reserve samples and hold the reserve samples using 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 [21 CFR 111.83(b)(1)]. Furthermore, the reserve samples must be identified with the batch, lot, or control number and must be kept for at least one (1) year past the shelf life date (if shelf life dating is used), or for at least two (2) years from the date of distribution of the last batch of dietary supplements associated with the reserve sample [21 CFR 111.83(b)(2)-(3)]. The reserve sample must also contain at least twice the quantity necessary for all tests or examinations to determine whether or not the dietary supplement meets product specifications [21 CFR 111.83(b)(4)]. 
 
Your response states that you “will move from retaining products for their (b)(4) year shelf life to (b)(4) years going forward.” Please note that you must comply with the provisions of 21 CFR 111.83(b)(3), which in some situations may result in retaining reserve samples beyond 2 years if expiration dating is not used.
 
You should notify this office in writing within fifteen (15) working days from your receipt of this letter of the specific steps that you have taken to correct the violations listed in this letter. Your response should include documentation of the corrective actions that you have taken or that you plan to take to correct these violations, including the specifics of what methods and controls you have implemented or plan to implement to prevent the recurrence of the violations. If corrective actions cannot be completed within 15 working days of receiving this letter, please state the reason for the delay and include a timetable for the implementation of the remaining corrections.
 
Your written response should be sent to Lynn S. Bonner, Compliance Officer at the address noted above. If you have any questions concerning this letter, please contact Compliance Officer Bonner at 215-717-3074 or by email at Lynn.Bonner@fda.hhs.gov.
 
Sincerely,
/S/
Kirk Sooter
District Director
Philadelphia District
 
cc:      
Pennsylvania State Department of Agriculture
Bureau of Food Safety and Laboratory Services
2301 North Cameron Street
Harrisburg, PA 17110-9408
Attention: Dr. Lydia Johnson, Director