ImprimisRx Pharmacy LLC – FDA Warning Letter, Aug 1, 2016

From June 28 to August 1, 2016, an FDA inspection of ImprimisRx PA, Inc. identified serious deficiencies in drug production, posing patient risks. The firm received a Form FDA 483 on August 1, 2016.

Violations included adulterated drug products under FDCA section 501(a)(2)(A) due to insanitary conditions. Specifically, inadequate cleaning procedures for beta-lactam product work surfaces and utensils were observed, with (b)(4) alone potentially ineffective in deactivating beta-lactam and preventing cross-contamination. Insufficient controls to prevent cross-contamination were also noted, with multiple batches of different drug products, including beta-lactams, present in the same production areas. Furthermore, FDA analysis of a product sample revealed fibrous material consistent with wood, leading to adulteration under FDCA section 501(a)(1). Introduction of such adulterated drugs into interstate commerce is prohibited under FDCA section 301(a).

ImprimisRx committed to ceasing production of powdered penicillin and beta-lactam formulations effective November 10, 2016, which FDA acknowledges as adequately addressing concerns, pending follow-up verification. FDA strongly recommends a comprehensive assessment of operations. The firm must respond within fifteen working days with corrective actions and prevention plans, or reasons for delay. Failure to comply may result in legal action.