Warning Follows 483 to Abba Pharma

MAITLAND, Fla.FDAs Florida District office issued a warning letter to Abba Pharma, Tampa, Fla., in early February, following up on a site inspection the agency performed in August 2010. According to the agency, its inspectors found serious violations of the cGMPs (current good manufacturing practices) for dietary supplements, causing its product Nephronex Liquid Dietary Supplement to be adulterated. Further, several food products were tested and found to be misbranded as they did not meet label claims for several nutrients; they were also promoted online with therapeutic claims that position the products as drugs.

Several lots of Proteinex® products were analyzed by FDA, and found to contain significantly greater quantities of phosphorus, sodium and potassium than declared on the product labels. Further, claims for the Proteinex products, made online at LlorensPharm.com, suggested the products could help repair tissue and prevent tissue breakdown, and would be helpful for those with cancer, HIV/AIDS and people undergoing dialysis. The use of such claims, and lack of appropriate labeling, causes the products to be both new and misbranded drugs.

Regarding the cGMP inspection, FDA issued a 483 inspection report on Aug. 30 to Abba Pharma, noting several deficiencies in its production of the Nephronex supplement. While the company did respond to the 483 issues in a Sept. 2, 2010, letter, FDA found the responses to be inadequate in all cases. For example, the 483 noted batch records for the release of the product did not show finished product testing to verify identity, purity, strength and composition; while the company response stated it has draft SOPs for testing specs, the company did not provide documentation that the specific batch underwent appropriate testing. Other concerns related to establishment of product specifications for finished batches of products; established component specifications for each ingredient; performed identity testing on all raw components; calibration of instruments used in testing and manufacturing; and failure to prepare and follow a written master manufacturing record (MMR).