| Public Health Service Food and Drug Administration |
Florida District |
Department of Health and Human Services
CERTIFIED MAIL
RETURN RECEIPT REQUESTED
WARNING LETTER
FLA-11-16
February 9, 2011
Mr. Carlos Gomez
President
Abba Pharma, Inc.
5001 W. Nassau St.
Tampa, FL 33607-3814
Dear Mr. Gomez:
From August 9, 2010 to August 30, 2010, the U.S Food and Drug Administration (FDA) inspected your facility located at 5001 W. Nassau St., Tampa, Florida. Our investigators collected samples of “Proteinex® Liquid Predigested Protein 15 and 18 GRAMS (Black Cherry, Lemon Lime, and Grape),” “Proteinex® Liquid Predigested Protein 100 Calories,” and “Proteinex® Wound Care” during the inspection of your facility. FDA analyzed these products and found them to be misbranded under section 403 of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 343]. Also, the inspection revealed serious violations of FDA’s Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling or Holding Operations for Dietary Supplements (CGMP) regulations for Dietary Supplements, under Title 21, Code of Federal Regulations (CFR), Part 111 (21 CFR Part 111). These violations cause your dietary supplement product, Nephronex Liquid Dietary Supplement, to be adulterated within the meaning of section 402(g)(1) of the Act [21 U.S.C. § 342(g)(1)] in that this product has been prepared, packed, or held under conditions that do not meet CGMP requirements for dietary supplements.
Further, FDA has reviewed your labeling for your products, Proteinex Liquid Predigested Protein, Proteinex Wound Care, and Nephronex Liquid Dietary Supplement, including the labeling of these products on your website, at the Internet address www.llorenspharm.com, and has determined that these products are promoted for conditions that cause your products to be drugs under section 201(g)(1)(B) of the Act [21 U.S.C. § 321]. The therapeutic claims on your website establish that the products are drugs because they are intended for use in the cure, mitigation, treatment, or prevention of disease. The marketing of the product with these claims violates the Act. You may find the Act and FDA regulations through links on FDA's home page at http://www.fda.gov.
Misbranded Foods
During the inspection, our investigators collected various samples of your Proteinex® Liquid Predigested Protein 15 and 18 GRAMS (Black Cherry, Lemon Lime, and Grape) products (lots 9E02, 9J02, 9K05, 9L02, 090612, 0A02, 0B05, 0F03, 0F05, 0F05, 0G01, 0F02), Proteinex® Wound Care WC product (lot 0D03), and Proteinex® Liquid Predigested Protein 100 Calories products (lots 0E04, 9G02). Based on our analysis of these samples, which was completed between September 23, 2010 and November 1, 2010, we concluded that these products are misbranded under section 403(a)(1) of the Act [21 USC 343(a)(l)], in that the labels are false and misleading because the amounts of phosphorus, sodium, and potassium found in them are greater than the amounts declared on the product labels. The findings are as follows:
Sample No. | Product Name, Size, Expiration | Lot No. | Nutrient | Label declaration | Original Analysis | Check Analysis |
596534 | Proteinex 18 GRAMS, 8 oz., Black Cherry, Exp. 4/11 | 9E02 | Phosphorus (mg/serving) | 0 | 222mg | 214mg |
596535 | Proteinex 18 GRAMS, 1 oz., Black Cherry, Exp. 8/11 | 9J02 | Phosphorus (mg/serving) | 0 | 224mg-239mg | 225mg -249mg |
596536 | Proteinex 18 GRAMS, 1 oz., Black Cherry, Exp. 9/11 | 9K05 | Phosphorus (mg/serving) | 0 | 232mg-236mg | 241mg - 256mg |
596537 | Proteinex 18 GRAMS, 30 oz., Black Cherry, Exp. 10/11 | 9L02 | Phosphorus (mg/serving) | 0 | 238mg | 220mg |
601146 | Proteinex 18 GRAMS, 30 oz., Black Cherry Exp. 6/11 | 090612 | Phosphorus (mg/serving) | 0 | 233mg-238mg | 222mg – 228mg |
640272 | Proteinex 18 GRAMS, 30 oz., Black Cherry, Exp. 12/11 | 0A02 | Phosphorus (mg/serving) | 0 | 34mg | 35.5mg |
640273 | Proteinex 15 GRAMS, 16 oz., Exp. 5/12 | 0B05 | Phosphorus (mg/serving) | 0 | 394mg | 429mg – 437mg |
640274 | Proteinex 18 GRAMS, 30 oz., Lemon Lime, Exp. 5/12 | 0F05 | Phosphorus (mg/serving) | 0 | 229mg – 310mg | 300mg – 312mg |
640255 | Proteinex 100 Calories, 16 oz., Black Cherry, Exp. 6/11 | 9G02 | Phosphorus (mg/serving) | 0 | 76.8mg | 80.7mg |
Sodium (mg/serving) | 5mg | 9.49mg (189.8%) | 10.1mg (202%) | |||
Potassium (mg/serving) | 13mg | 8.42mg (64.8%) | 8.9mg (68.4%) | |||
640256 | Proteinex 100 Calories, 30 oz., Black Cherry, Exp. 4/12 | 0E04 | Phosphorus (mg/serving) | 0 | 277mg | 305mg |
Sodium (mg/serving) | 5mg | 15.4mg (308% | 15.9mg (318%) | |||
Potassium (mg/serving) | 13mg | 16.4mg (126.1%) | 16.9mg (130%) | |||
640257 | Proteinex Wound Care, 30 oz., Grape, Exp. 3/12 | 0D03 | Phosphorus (mg/serving) | 0 | 156mg | 173mg |
Sodium (mg/serving) | 4mg | 14.8mg (370%) | 15.6 (390%) | |||
640258 | Proteinex 18 GRAMS, 30 oz., Lemon Lime, Exp. 5/12 | 0F05 | Phosphorus (mg/serving) | 0 | 297mg | 295mg |
Sodium (mg/serving) | 5mg | 27.3mg (546%) | 25.1mg (502%) | |||
640259 | Proteinex 18 GRAMS, 30 oz., Black Cherry, Exp. 5/12 | 0F03 | Phosphorus (mg/serving) | 0 | 274mg | 236mg |
Sodium (mg/serving) | 5mg | 25.4mg (508%) | 21.6mg (432%) | |||
640260 | Proteinex 18 GRAMS, 30 oz., Grape, Exp. 6/12 | 0G01 | Phosphorus (mg/serving) | 0 | 384mg | 425mg |
Sodium (mg/serving) | 5mg | 22.7mg (454%) | 23.6mg (472%) | |||
Potassium (mg/serving) | 13mg | 7.24mg (55.7%) | 7.6mg (58.5%) | |||
640267 | Proteinex 15 GRAMS, 30 oz., Exp. 5/12 | 0F02 | Phosphorus (mg/serving) | 0 | 266 | 324 |
Sodium (mg/serving) | 4mg | 21.1mg (527.5%) | 27mg (675%) | |||
Potassium (mg/serving) | 11mg | 12.5mg (113.6%) | 16.8mg (152.7%) |
We have included copies of the analytical results with this letter.
Adulterated Dietary Supplement
The inspection revealed that your Dietary Supplement product, Nephronex Liquid, is adulterated within the meaning of Section 402(g)(1) of the Act [21 U.S.C. § 342(g)(1)] in that the dietary supplement has 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 in a form FDA-483, Inspectional Observations, at the conclusion of our inspection on August 30, 2010.
Our inspection revealed the following violations:
1) Your firm failed to conduct testing of either every finished dietary supplement batch or a subset of the finished dietary supplement batches that you identify through a sound statistical sampling plan to determine whether the finished product meets established product specifications for identity, purity, strength, and composition of the dietary supplement, as required by 21 CFR 111.75(c).
- Specifically, the batch record for the released finished product, Nephronex Liquid Dietary Supplement (8 oz.) (Lot 0G02), lacked evidence of finished product testing to verify its identity, purity, strength, and composition.
We reviewed your response dated September 2, 2010, and concluded that it is inadequate. Your letter stated that you have drafted Standard Operating Procedures (SOPs) for finished and in-process testing specifications, but you did not provide documentation that the above batch of Nephronex Liquid Dietary Supplement product had undergone finished product testing and did not provide documentation of your plan to ensure finished product testing is conducted on future batches. In addition, your records indicate that you performed microbiological tests on the finished product, but this type of test does not verify the identity, purity, strength, and composition of the finished product, as required by 21 CFR 111.75(c).
2) Your firm failed to provide records to show that you had established product specifications, as required by 21 CFR 111.95(b)(1), for the identity, purity, strength, and composition of the finished batch of each dietary supplement that you manufacture, as required by 21 CFR 111.70(e).
- Specifically, you were not able to provide any records to show that you established product specifications for the identity, purity, strength, and composition of the finished batch of Nephronex Liquid Dietary Supplement product.
We reviewed your response dated September 2, 2010, and concluded that it is inadequate because you did not provide any records to show that you established finished product specifications for the identity, purity, strength and composition of the finished batch of Nephronex Liquid Dietary Supplement product.
3) Your firm failed to provide records, as required by 21 CFR 111.95(b)(1) to show that you had established specifications for each component necessary to ensure that specifications for the purity, strength, and composition of the dietary supplements manufactured using the components are met, as required by 21 CFR 111.70(b)(2).
- Specifically, your firm uses Thiamine HCl, Riboflavin Phosphate, Pyridoxine HCl, Cyanocobalamin, Ascorbic Acid, Folic Acid, Niacinamide, D-Biotin, Calcium D-Pantothenate, Propylene Glycol USP, Glycerine 99.5%, Methylparaben, Propylparaben, Potassium Sorbate, Cremophor RH40, Triethanolamine, Aspartame, Orange Oil, and Purified Water in your Liquid Dietary Supplement product, but you failed to provide records to show that you established component specifications for each of these components.
We reviewed your response dated September 2, 2010, and concluded that it is inadequate because you did not provide any records to show component specifications for the components used to manufacture your Nephronex Liquid Dietary Supplement product.
4) Your firm failed to conduct at least one appropriate test or examination to verify the identity of a dietary ingredient, prior to its use, as required by 21 CFR 111.75(a)(1)(i).
- Specifically, your firm uses Thiamine HCl, Riboflavin Phosphate, Pyridoxine HCl, Cyanocobalamin, Ascorbic Acid, Folic Acid, Niacinamide, D-Biotin, and Calcium D-Pantothenate dietary ingredients in your Nephronex Liquid Dietary Supplement product, but you firm do not perform an identity test or examination on any of these dietary ingredients used in this dietary supplement.
We reviewed your response dated September 2, 2010 and concluded that it is not adequate. Your letter stated that you have drafted SOPs for incoming raw material used in the manufacture of your products and that it will contain specific material release specifications prior to release.
You also indicated that a “Vendor Qualification SOP” will be drafted within the next two weeks stipulating your requirements to qualify a vendor. Your response does not specify, and you did not provide, supporting documentation on how you intend to ensure that you will verify the identity of each dietary ingredient used in the dietary supplements you manufacture. Also, the regulations allow for supplier (vendor) qualification to confirm the identity of components, other than dietary ingredients, and the use of certificate of analysis after qualification of the supplier (21 CFR 111.75(a)(2)(ii)). Supplier qualification only applies to components (excluding dietary ingredients) used in the manufacture of dietary supplements.
5) Your firm failed to establish and follow written procedures for calibrating instruments and controls that you use in manufacturing or testing a component or dietary supplement, as required by 21 CFR 111.25(a). Further, your firm failed to make and keep documentation of calibration, each time the calibration is performed, for instruments and controls that you use in manufacturing or testing a component or dietary supplement, as required by 21 CFR 111.35(b)(3).
- Specifically, you did not have records of calibration for the scales used to weigh raw materials in the manufacturing of your dietary supplement products.
We reviewed your response dated September 2, 2010 and concluded that it is not adequate because you did not provide supporting documentation such as your SOP and records of calibration for verification.
6) 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, your firm was unable to provide a written master manufacturing record for the Nephronex Liquid Dietary Supplement product manufactured at your facility.
We have reviewed your response dated September 2, 2010 and concluded that is not adequate because you did not provide any MMRs for verification.
7) Your firm failed to make and keep records that show that water, when used in a manner such that the water may become a component of the dietary supplement, meets the requirements of 21 CFR 111.15(e)(2), as required by 21 CFR 111.23(c).
- Specifically, your firm was unable to provide records to show that the water used in your Nephronex Liquid Dietary Supplement product complies with applicable Federal, State, and local requirements and does not contaminate the dietary supplement.
We have reviewed your response dated September 2, 2010 and have concluded that is not adequate because you stated you are in the process of installing a new water system to comply with the requirement. We will verify the adequacy of your proposed corrections for observations 6 and 9 during our next inspection.
Unapproved and Misbranded Drugs
Examples of some of the claims observed on your labeling and website, www.llorenspharm.com, include:
From the Label of the Nephronex Liquid Dietary Supplement
- "A Multi-Vitamin Supplement Rich in B-Complex for People Undergoing Dialysis Treatment"
From the webpage titled Proteinex Liquid Predigested Protein
- "Helps to repair tissue and prevent tissue breakdown"
- "Who can benefit from Proteinex ...
- Wound Care/burns ...
- Dialysis associated with renal failure
- HIV/AIDS
- Cancer"
From the webpage titled ProteinexWound Care
- "Applications:
- Pressure ulcers ...
- Post-Surgical Wounds
- Diabetic Foot Ulcers
- Venous Stasis Ulcers"
In addition, the name of your product, Proteinex Wound Care suggests that your product is intended for use in the treatment of wounds.
Because your products, Nephronex Liquid Dietary Supplement, Proteinex Liquid Predigested Protein, and Proteinex Wound Care, are not generally recognized as safe and effective when used as labeled, they are "new drugs" as defined under section 201(p) of the Act [21 U.S.C. § 321(p)]. New drugs 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, because your products, Nephonex Liquid, Proteinex Liquid Predigested Protein, and Proteinex Wound Care, are offered for conditions that are not amenable to self-diagnosis and treatment by individuals who are not medical practitioners, adequate directions cannot be written so that a layman can use the product safely for their intended uses. Thus, their labeling fails to bear adequate directions for their intended uses, causing them to be misbranded under section 502(f)(1) of the Act [21 U.S.C. § 352(f)(1)]. The introduction of a misbranded drug into interstate commerce is a violation of § 301(a) of the Act [21 U.S.C. § 331(a)].
The above violations are not meant to be an all-inclusive list of the violations that exist in connection with your products and their labeling. You are responsible for ensuring that all of your products are in compliance with the Act and FDA regulations. Failure to promptly correct the violations specified above may result in enforcement action without further notice. Such enforcement action may include seizure of illegal products and/or injunctions against manufacturers and distributors of illegal products [21 U.S.C. § § 334 and 332].
Please respond in writing within fifteen (15) working days from your receipt of this letter. Your response should outline the specific actions you are taking to correct these violations and to prevent similar violations from occurring in the future. If you cannot complete all corrections before you respond, you should explain the reason for your delay and state when you will correct any remaining violations.
Please send your reply to the Food and Drug Administration, Attention: Carla A. Norris, Compliance Officer, 555 Winderley Place, Suite 200, Maitland, Florida 32751. If you have questions regarding any issues in this letter, please contact Ms. Norris at (407) 475-4730.
Sincerely,
/S/
Emma R. Singleton
Director, Florida District
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