Posted March 13, 2013

Liquid Supplements Not Properly Manufactured Despite Certification

On February 22, 2013, the FDA issued a warning letter to Organics Corporation of America, dba Ambix Laboratories, following a facility inspection which found the company’s dietary supplements Baby Plex Vitamin Drops, Carnitine Liquid, and Optimal Nutritional Liquid to be adulterated because they were prepared, packed, or held under conditions that violate Current Good Manufacturing Practices for dietary supplements.

(See’s Reviews of Multivitamin and Multimineral Supplements, Including Pre Natal and Children’s Formulas, Acetyl-L-Carnitine Supplements and Nutrition Powders and Drinks for tests of related products.)

These violations include failure to conduct at least one appropriate test or examination to verify the identity of any component that is a dietary ingredient and failure to verify that finished batches of dietary supplements met product specifications for identity, purity, strength, composition, and for limits on those types of contamination that may adulterate or that may lead to adulteration.

The company’s initial attempts to resolve these violations were found to be inadequate the by the FDA.

Other violations include failure to make and keep documentation, in individual equipment logs, of the date of the use, maintenance, cleaning, and sanitizing of equipment and failure to collect representative samples of each unique lot of components and packaging to determine whether the components and packaging meet specifications. The FDA also noted that certain components of the company’s dietary supplements were not stored in an appropriately temperature-controlled environment, as required by federal regulations.

The FDA acknowledged Ambix’s written response to the agency, which stated that corrective actions had been taken to remedy these violations, and said it would look to confirm these changes during the next inspection.

Ambix Laboratories is registered as CGMP compliant by NSF International, an independent auditing company that many dietary supplement manufacturers rely on to assess their compliance with federal regulations.

See Related Warnings:

FDA Finds Manufacturing Violations At NSF-Certified Supplement Facility

Maker of Liquid Omega-3 Supplements Warned For Manufacturing Violations

For more information about the FDA’s warning letter, use the link below.