Compounder Cited for Sterile Manufacturing Violations

September 14, 2016

FDA sent a warning letter to an Illinois compounding pharmacy for violations of the Federal Food, Drug, and Cosmetic Act.

FDA issued a warning letter to Central Illinois Compounding, Inc. dba Preckshot Professional Pharmacy following an inspection of the company’s Peoria Heights, IL, facility from April 15, 2015 to May 14, 2015. The company was cited for improper sterile manufacturing practices and producing drugs that violate the Federal, Food, Drug, and Cosmetic Act (FDCA).

Investigators found deficiencies in the company’s sterile manufacturing practices, including the failure to use a sporicidal agent in compounding areas and failing to assure the agency that hoods provided adequate protection of the ISO 5 area. FDA stated in the letter that some of the company’s planned corrective and preventive actions were inadequate.

“Your response states that dynamic smoke studies were performed in the ISO-5 areas (b)(4). However, the certification report for the ISO 5 areas that FDA collected during the inspection does not state the smoke studies were performed under dynamic conditions. In addition, the report indicated neither what activities were simulated nor the number of personnel present in the cleanroom during the study. Furthermore, you have not submitted a more recent report, showing that your firm has performed smoke studies under dynamic conditions,” FDA stated in the letter.

The agency recommends the company assess its operations, especially its aseptic processing operations. “You are responsible for investigating and determining the causes of the violations identified above and for preventing their recurrence or the occurrence of other violations. It is your responsibility to ensure that your firm complies with all requirements of federal law, including FDA regulations,” FDA stated.

Source: FDA