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FDA sent a warning letter to ACRX Specialty Pharmacy Inc. detailing violations of the Federal Food, Drug, and Cosmetic Act and deficiencies in sterile manufacturing practices.
FDA sent a warning letter, dated July 24, 2020 to ACRX Specialty Pharmacy Inc. after an inspection of the company’s Las Vegas, NV, facility found the company failed to meet the conditions of section 503A of the Federal Food, Drug, and Cosmetic Act (FDCA). Inspectors also observed deficiencies in the company’s practices for making sterile drugs. The FDA inspection was conducted from February 25, 2019 to March 20, 2019.
In the letter, the agency states that the company did not meet the conditions of section 503A of FDCA and that products that were intended to be sterile were “prepared, packed, or held under insanitary conditions.” The inspector observed operators moving from a classified cleanroom area to a non-classified area and returning without replacing gowning and gloves. The inspector also observed an operator fill anew bottle of product with the remaining quantity of a used bottle of sterile product. A door between the anteroom and the unclassified area was held open by an operator for an extended period of time while supplies were gathered.
FDA also stated that the company failed to perform adequate smoke studies and “media fills were not performed under the most challenging or stressful conditions. Therefore, there is a lack of assurance that your firm can aseptically produce drug products within your facility.”
In addition, a variety of current good manufacturing practice violations observed during the inspection included failure to establish and follow appropriate written procedures to prevent microbiological contamination, failure to establish an adequate environmental monitoring system in aseptic processing areas, failure to establish an adequate system for maintaining equipment, and failureto establish adequate written responsibilities and procedures for the quality control unit.