Unsanitary Practices Lead to FDA Warning

CINCINNATIFDA found unsanitary personnel practices and other GMP (good manufacturing practice) violations when it inspected Parrillo Performance's Fairfield, OH, facility in February 2012. In a warning letter to owner John Parrillo, FDA noted its inspectors saw an employee reach elbow deep into a mixing bowl while manufacturing Graham Cracker Energy Bars, but only washed and sanitized his hands and wrists beforehand.

FDA also said a different employee reached into the same mixing bowl while wearing a diamond ring, and two male employees with facial hair were observed manufacturing without wearing beard-nets. FDA said this shows Parrillo Performance failed to establish and follow written procedures for personnel, including the prevention of microbial contamination from sick or infected workers, which violate the Federal Food, Drug and Cosmetic Act (FFDC).

FDA also found numerous other GMP violations at the plant, and indicated them on a FDA-483, Inspectional Observations, form issued at the conclusion of the inspection. Parrillo Performance did not have component specifications for its protein powders and different energy bars; these specs help ensure products have the claimed amounts stated on the supplement label. The company also did not conduct identity testing on dietary ingredients used in its Graham Cracker Energy Bar product, and FDA said it did not qualify its suppliers' certificates of analysis (COA) by conducting its confirmation own tests.

FDA also found Parrillo Performance did not have written quality control (QC) procedures, follow written master manufacturing records (MMR) for each formulation, have complete information on its batch production records (BPR) for two of its products, follow written procedures for packaging and labeling, have written procedures for product complaints, follow written procedures for returned supplements and have written procedures for manufacturing operations. It also did not follow written procedures for calibrating, inspecting and cleaning equipment, nor did it have procedures for cleaning the facility.

FDA said Parrillo Performance's March 2012 response was inadequate because it did have documentation to indicate that the company corrected any of the deficiencies observed during the inspection.

INSIDER's Take:

FDA has taken more interest in personnel issues lately. In this instance, it said dietary supplements must be made in a clean facility, and a sanitary facility is only possible when employees follow written personnel procedures. Last week, the agency released a warning letter to United Nutrition saying its QC director was not qualified because she does not have the necessary experience, knowledge and level of training. This shows companies need to make sure their employees have the required job experience and also follow the rules, rules that must be written down.

As FDA has noted in other warning letters, procedures must also be written down for other manufacturing aspects, such as specifications, labeling, cleaning, returned supplements, etc. Also, a company must offer a detailed response to a 483 form with a outline of exactly how the company resolved the issues FDA noticed during the inspection. If a company fails to do so, it will receive a warning letter, much like Parrillo Performance's.