Warning Letters continue as FDA maintains cGMP vigilance
Minnesota’s WellnessOne World and Florida-based CJ Labs, Inc. have received warning letters for “serious violations of the Current Good Manufacturing Practice (CGMP) regulations for dietary supplements”.
Serious questions
At the recent Council for Responsible Nutrition (CRN) conference in Rancho Palos Verdes in California, Daniel Fabricant, PhD, director of the FDA’s Division of Dietary Supplement Programs told attendees that the agency GMP audits to date have not had “much drill down on the analytical science”.
“We’re asking the first level of questions,” he said. “Expect more serious questions in the future on supplier qualification.”
According to FDA data, only seven GMP inspections occurred in 2008, which increased to 34 in 2009, 84 in 2010. As of September 13 of this year, there were 145 inspections.
Supplier qualification
WellnessOne World received a warning letter dated November 16 for dietary supplement cGMP Violations.
“During the inspection our investigators found a number of serious violations of the Current Good Manufacturing Practice (CGMP) regulations for dietary supplements, Title 21, Code of Federal Regulations (CFR), Part 111,” states the letter.
“These 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.”
Please click here to read the full letter.
FDA alleges that the firm “failed to qualify the suppliers of components other than dietary ingredients by establishing the reliability of the suppliers’ certificates of analysis through confirmation of the results of the suppliers’ tests or examinations, before using those components […] and failed to maintain documentation of how the supplier was qualified”.
WellnessOne was also warned for promoting products for drug conditions.
483
CJ Labs, Inc. has also been issued with a warning letter for “serious violations” of cGMPs. Following an inspection of the company’s facilities in May/June of this year the company was issued with a Form FDA 483 listing the violations, which included
The 483 included “a number of the violations that cause your dietary supplement products, Milk Thistle and L-Carnitine, to be adulterated […] in that the products have been prepared, packed, or held under conditions that do not meet CGMP requirements for dietary supplements.”
Like WellnessOne, CJ Labs was also warned for promoting products for “conditions that cause them to be drugs”.
