Batch testing among litany of GMP failures for Connecticut firm

14-Mar-2011 - Last updated on 15-Mar-2011 at 15:54 GMT

Another FDA '483' inspection, another list of problems

The Food and Drug Administration (FDA) has issued a warning letter to a Connecticut-based manufacturer of vitamins, minerals and herbal extracts for a host of GMP breaches that include failure to test final batches.

The FDA wrote to RHG & Company Inc/Vital Nutrients on February 16 to inform the manufacturer that its batch testing methods did not meet Good Manufacturing Practice (GMP) specifications for products including vitamin D supplements, ‘PreNatal’ multivitamins and garlic extracts.

The letter gave RHG 15 days to get its house in order and followed initial FDA inspection in August and September in 2010 which had provoked actions the agency determined were inadequate to meet GMP standards.

“These violations cause your dietary supplement products PreNatal Multi-Nutrients Capsules, Garlic Extract 300 mg Capsules, Milk Thistle 80% Capsules, and Vitamin D3 5000iu Capsules 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 products have been prepared, packed, or held under conditions that do not meet CGMP regulations for dietary supplements,” FDA wrote.

RHG/Vital wrote a letter to the FDA last November outlining some of the measures it had taken to correct the deficiencies in the FDA ‘483’ inspection, but the FDA said the actions weren’t good enough.

“Your letter stated that you will conduct full profile finished product testing until you ‘have adequate data and documentation on file to exempt any testing’,” the FDA wrote.

“However, you did not provide documentation that you conducted finished product testing of each finished batch of dietary supplement to verify that each batch met the finished product specification for strength and did not provide documentation that your firm is currently conducting such finished product testing for strength.”

Aside from the batch testing violations, the FDA found the company had not established component specifications for purity, strength and composition. In the case of garlic the company had simply noted: “No scientifically valid method currently exists to quantify active ingredients or marker compounds.”

The FDA said failure to specify bulk powder density was another failing, something the company disputed. In response the FDA wrote:

“The bulk density of the blend will be different from each of the individual bulk densities of the raw materials. Your response is inadequate because it still does not establish a specification for bulk powder density of the in-process product or propose another suitable in-process parameter to address finished capsule weight issues.”

The company was also charged with failing conduct material reviews and failing to maintain master manufacturing records for each of its products, “and for each batch size, to ensure uniformity in the finished product from batch to batch…”.