FDA 483 - Life Science Pharmacy Inc - November 20, 2019

This FDA Form 483 documents observations from an inspection. The facility uses non-pharmaceutical grade components, specifically non-USP grade (b)(4) (b)(4) (b)(4) (b)(4), in the formulation of non-sterile drug products. Examples include Rx (b)(4), CHLORAL HYDRATE(G) SUSP 500MG/5ML (10/1/19), Rx (b)(4), NYSTATIN ORAL SUSP(RASPBERRY) 100,000U/ML (9/16/19), and Rx (b)(4), BUTYRATE ENEMAS (100mM/LITER) 100MM/LITER (10/25/19).

Observations also include deficiencies in environmental controls and aseptic processing. ISO-5 classified areas were not certified under dynamic conditions; uni-directional airflow was not verified operationally. A smoke study from July 2019 was only performed under static conditions for the ISO 5 (b)(4) flow BSC, not the ISO 5 (b)(4) LFH, both used for sterile drug products. Media fills simulating worst-case aseptic production operations have not been successfully completed or documented in the last year. Pressure differentials between areas with different air classifications were not monitored prior to or during sterile drug production, despite the presence of (b