Inspections, Compliance, Enforcement, and Criminal Investigations
Reaction Nutrition, L.L.C. 5/8/12
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
900 U.S. Customhouse
2nd and Chestnut Streets
Philadelphia, PA 19106
RETURN RECEIPT REQUESTED
May 8, 2012
Frank Bedoloto, CEO, Partner
Reaction Nutrition, L.L.C.
230 East Main Street
Carnegie, PA 15106-2700
Dear Mr. Bedoloto:
The U.S. Food and Drug Administration (FDA) conducted an inspection of your dietary supplement manufacturing and packaging facility, located at 230 East Main Street, Carnegie, PA from November 29 through December 20, 2011. During the inspection, our investigators found a number of significant violations of the Current Good Manufacturing Practice (CGMP) regulations for dietary supplements, Title 21, Code of Federal Regulations (CFR), Part 111. These CGMP 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 the dietary supplements have been prepared, packed, or held under conditions that do not meet CGMP regulations for dietary supplements. Our investigators' observations were noted on form FDA 483, lnspectional Observations, which was issued to you on December 6, 2011.
In addition, our investigators collected and reviewed samples of the labeling of your dietary supplement products during the inspection of your facility. Based on our review of your product labeling, we have determined that your Live Capsules" product is promoted for conditions that cause it to be a drug within the meaning of section 201(g)(1)(B) of the Act [21 U.S.C. § 321(g)(1)(B)]. The therapeutic claims on your labels establish that this product is a drug because it is intended for use in the cure, mitigation, treatment, or prevention of disease. You may find the Act and the Dietary Supplement CGMP regulations through links on FDA's home page at http://www.fda.gov.
Dietary Supplement CGMP Violations
The inspection revealed the following violations:
1. Under 21 CFR 111.123(b)(2), no finished batch of dietary supplements may be released for distribution by quality control personnel unless it meets all product specifications established in accordance with 21 CFR 111.70(e). However, your firm's quality control personnel released finished batches of dietary supplements which did not conform to product specifications established in accordance with 21 CFR 111.70(e).
Specifically, your firm's quality control personnel released Reaction Nutrition Velocity dietary supplement, Lot (b)(4) on May 11, 2011 although this lot of finished product did not include a dietary ingredient that is a specified component of this product. The batch production record (BPR) for Lot (b)(4) and product label for Reaction Nutrition Velocity specify the use of the ingredient, Uva Ursi, with raw material ID (b)(4) but the BPR for Lot (b)(4) documents that Uva Ursi was not included as an ingredient in this batch of product.
Your firm's quality control personnel also released ProR.x Thermo lean dietary supplement, Lot (b)(4) and Lot (b)(4) on November 29, 2011, although these lots of finished product did not meet the established product specifications for capsule component. Specifically, the BPRs for Lot (b)(4) and Lot (b)(4) specify the use of (b)(4) capsules sized, (b)(4) with raw material ID# (b)(4), but the BPRs for these lots document the use of (b)(4) capsule with Lot (b)(4).
• Additionally, ProRx Thermolean dietary supplement, Lot (b)(4) did not meet the established product specifications for capsule weight. Specifically, the BPR for Lot (b)(4) specifies that capsules must weigh within (b)(4) percent of (b)(4) mg, but the BPR for this lot documents that the capsules selected for weight validation exceeded this weight specification.
We have reviewed your response to the FDA-483 dated January 4, 2012. You stated that you planned to create a new quality control manager position that is independent from the production department. Your response is inadequate because you did not include any supporting documentation of your corrective action. We will evaluate the adequacy of any proposed corrective action during our next inspection of your facility.
2. 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). Specifically, our investigators found that you did not prepare a MMR for any of your softgel dietary supplement products.
We have reviewed your response to the FDA-483 dated January 4, 2012. You stated that you planned to design a new procedure for softgel MMRs and implement this procedure by the end of the first quarter of 2012. However, your response is inadequate because you did not provide any supporting documentation of your corrective action or specify what procedures you would follow during the first quarter of 2012. We will evaluate the adequacy of any proposed corrective action during our next inspection of your facility.
3. When our investigators requested copies of your MMRs, you produced blank BPRs for certain products and stated that your blank BPRs function as an MMR. Based on this representation, we reviewed these documents as MMRs. Your MMRs for your Reaction Nutrition Velocity and ProRx Thermolean dietary supplement products failed to include all the information required by 21 CFR 111.210. Specifically, these MMRs failed to include a representative label or a cross-reference to the physical location of the actual or representative label, as required by 21 CFR 111.210(g).
Further, your MMRs also failed to identify a specification for a point, step, or stage in the manufacturing process where control is necessary to ensure the quality of the dietary supplement as required by 21 CFR 111.205(b)(1). Specifically, the MMRs for your Reaction Nutrition Velocity, ProRx Thermolean, and Predator Nutrition Geranamine dietary supplement products list a lower limit for the established blend time, but not an upper limit. For example, the MMRs for Reaction Nutrition Velocity, Lot (b)(4), ProRx Thermolean, Lot (b)(4) and Lot (b)(4), and Predator Nutrition Geranamine, Lot (b)(4) , state to "blend formula (b)(4)." Given that you have not identified an upper limit for the blend time, the specification you have set of (b)(4) does not assure uniformity and quality between batches of the same dietary supplement.
4. You failed to verify that your finished batches of dietary supplements meet finished product specifications for identity, purity, strength, composition, and for limits on those types of contamination that may adulterate or that may lead to adulteration of the finished batch, as required by 21 CFR 111.75(c). You may verify that these specifications are met by testing or examining (1) every finished batch or (2) a subset of finished batches for each of the dietary supplements you manufacture [21 CFR 111.75(c)]. If you test a subset of finished batches, you must identify the subset using a sound statistical plan [21 CFR 111.75(c)]. Because you did not identify such a subset of finished batches, you must test every finished batch of the dietary supplements manufactured at your firm. However, during the inspection you verbally confirmed to our investigators that you do not perform any finished product testing to verify the identity, purity, strength and composition of your dietary supplement products. Furthermore, your BPRs for the following released finished products lacked finished product testing to verify the identity, purity, strength, and composition:
a. Reaction Nutrition Velocity, (b)(4);
b. ProRx Thermolean, Lot (b)(4) and Lot (b)(4);
c. Predator Nutrition Geranamine, Lot (b)(4);
We have reviewed your response dated January 4, 2012, indicating that you are adding a final quality control lab examination procedure to your MMRs and BPRs and will implement this process by the end of the first quarter of 2012. However, your response is inadequate because you did not provide any supporting documentation of your corrective action or specify what procedures you would follow during the first quarter of 2012. We will evaluate the adequacy of any proposed corrective action during our next inspection of your facility.
5. You did not make and keep records of the written procedures for manufacturing operations as required by 21 CFR 111.375(b). Specifically, our investigators found that you lack standard operating procedures for the blending processes for all of the dietary supplement products manufactured at your facility.
We have reviewed your response dated January 4, 2012, indicating your intent to create a new quality control manager position and correct the 21 CFR 111.3 7 5(b) violation by the end of the first quarter of 2012. However, your response is inadequate because you did not provide any supporting documentation of your corrective action or specify what procedures you would follow during the first quarter of 2012. We will evaluate the adequacy of any proposed corrective action during our next inspection of your facility.
6. You did not establish and follow written procedures for when a returned dietary supplement is received as required by 21 CFR 111.503. Specifically, during the inspection you could not produce written procedures for handling returned dietary supplements.
Unapproved New Drug
During the inspection at your facility, our investigators collected labels associated with your products, including your Live Capsules product. Based on our review of your product labeling, we have determined that this product is promoted for conditions that cause it to be a drug within the meaning of section 201(g)(1)(B) of the Act. The therapeutic claims in your labeling establish that the product is a drug because it is intended for use in the cure, mitigation, treatment, or prevention of disease. The marketing of the dietary supplement product with these claims violates the Act.
Examples of some of the claims observed in your product labeling include:
Reaction Nutrition Live Capsules:
• "[H]elps keep your body in peak condition to fight and repel infections, viruses
• "[W]ill allow your body to fight off infectious agents without the drawbacks of
• "[I]ncreases the number of T-lymphocytes, which are while [sic] blood cells that
fight off infections."
Your Live Capsules product is not generally recognized as safe and effective for the above referenced uses and therefore, the product is a "new drug" under Section 201(p)(1) of the Act [21 U.S.C. § 321(p)(1)]. A new drug may not be legally marketed in the United States without prior approval from FDA as described in Section 505(a) of the Act [21 U.S.C. § 355(a)]. FDA approves a new drug on the basis of scientific data submitted by a drug sponsor to demonstrate that the drug is safe and effective.
Furthermore, your Live Capsules product is offered for conditions that are not amenable to self-diagnosis and treatment by individuals who are not medical practitioners. Therefore, adequate directions cannot be written so that a layman can use the product safely for its intended uses. Thus, this product is misbranded under Section 502(f)(1) of the Act [21 U.S.C. § 352(f)(1)], in that its labeling fails to bear adequate directions for its use. The introduction of a misbranded drug into interstate commerce is a violation of Section 301(a) of the Act [21 U.S.C. § 331(a)].
The violations cited in this letter are not meant to be an all-inclusive list of violations in your products and their labeling. It is your responsibility to ensure that your products are in compliance with the Act and its implementing regulations. We advise you to review your website, products labels, and other labeling and promotional materials for your products to ensure that the claims you make for your products do not cause them to violate the Act.
You should take prompt action to correct the violations cited in this letter and prevent their recurrence. Failure to do so may result in enforcement action by FDA without further notice, including seizure and/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 costs related to re-inspection. 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. Re-inspection-related costs means all expenses, including administrative expenses, incurred in connection with FDA's arranging, conducting, and evaluating the results of there-inspection and assessing and collecting there-inspection fees, 21 U.S.C. § 379j-31(a)(2)(B). For a domestic facility, FDA will assess and collect fees for re-inspection-related costs from the responsible party for the domestic facility. The inspection noted in this letter identified non-compliance materially related to a food safety requirement of the Act. Accordingly, FDA may assess fees to cover any costs related tore-inspection.
Within fifteen (15) working days from your receipt of this letter, please notify this office in writing of the specific steps you have taken to correct all of the violations described above. Include in your response documentation to show that correction has been achieved. Additionally, if another firm manufactures these products, identified above, your reply should include the name and address of the manufacturer. If the firm from which you receive these products is not the manufacturer, please include the name of your supplier, in addition to the manufacturer. If you cannot complete all corrections within 15 working days, please state the reason for the delay and the date by which you will complete the corrections.
Please send your written reply to Yvette Johnson, Compliance Officer at the address noted above. If you have any questions with regard to this letter, Ms. Johnson can be reached at 215-717-3077 or Yvette.Johnson@fda.hhs.gov.
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, Bureau Director