FDA Issues Warning to Vital Nutrients

MIDDLETOWN, Conn.Vital Nutrients received an FDA warning letter in mid-February from the agencys New England District Office in Stoneham, Mass. The letter notified the company that its Nov. 4, 2010, response to the FDA-483 report issued after a cGMP (current good manufacturing practice) inspection conducted in August and September 2010 is considered inadequate, and the products cited in the 483 report are considered adulterated. The products include PreNatal Multi-Nutrients Capsules, Garlic Extract 300 mg Capsules, Milk Thistle 80% Capsules and Vitamin D3 5000iu Capsules.

Violations observed in the 483 report included failure to conduct testing to confirm those finished products met specifications for strength of each ingredient; failure to establish component specifications for raw materials; failure to establish specifications in the master manufacturing records (MMR) to ensure the supplements meet spec for strength and composition, particularly related to bulk powder density; and failure to prepare and follow a written MMR for each unique formulation of supplement and for each batch size to ensure product uniformity between batches. FDA also cited concerns related to failure to routinely check equipment, specifically capsule counters, to ensure proper performance.

While Vital Nutrients submitted a response letter noting it would conduct full profile finished product testing, it provided no documentation that it is doing so; in addition, Vital Nutrients response to the issue of bulk powder density was considered inadequate because it still did not establish a spec for bulk powder density in-process nor propose another in-process parameter to address finished capsule weight issues. The company also stated in its response that it has begun preparing and following written MMRs for each batch size of supplement; however, it did not provide FDA with the MMRs, so the agency stated it would verify the situation has been addressed at its next inspection.