Alexander Infusion LLC dba Avanti Health Care Services — FDA 483 Findings

There is no written testing program designed to assess the stability characteristics of drug products.

Aseptic processing areas are deficient regarding systems for maintaining any equipment used to control the aseptic conditions, in that: Smoke studies have not been conducted under dynamic conditions and mimicking the most challenging preparations produced by personnel on a regula...

Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not established, written, and followed, in that: Media fill simulations have not been conducted under dynamic conditions mimicking the most stressful or challenging preparations/ worst case scenarios encountered by personnel producing sterile products on a regular basis to verify that operators, processing equipment or activities of the ISO 7 clean rooms do not alter or impede the unidirectional flow of air from the HEPA filters and for the REDACTED (b)(4) ISO 5 laminar flow hoods wher e drug products are aseptically processed .

Clothing of personnel engaged in the processing of drug products is not appropriate for the duties they perfo rm , in that: Non-sterile gowns are used to produce sterile preparations.

Aseptic processing areas are deficient-regarding the system for monitoring environmental conditions.

Each batch of drug product purporting to be sterile and pyrogen-free is not laboratory tested to determine conformance to such requirements, in that: Sterility testing of preparations utilizes a whose instructions require an incubation temperature of REDACTED (b)(4) not the REDACTED (b)(4) being used REDACTED (b)(4) since days incubated is not documented.