FDA 483 - Stewart Compounding Pharmacy - February 26, 2014

This FDA Form 483 document details observations from an inspection, focusing on deficiencies in the manufacturing of sterile drug products.

**Observation 1** identifies inadequate validation of sterilization processes. For Hydroxyprogesterone Caproate Lot #01132014 + 16756@6, the [REDACTED] sterilization process lacked documentation to support its capability of producing a sterile product, with the equipment use log only identifying the product and [REDACTED]. Furthermore, verification studies performed on the [REDACTED] were insufficient as they only represented [REDACTED] and not actual or simulated finished product sterilization. The [REDACTED] used for these studies was also not [REDACTED] or documented.

**Observation 2** notes that procedures to prevent microbiological contamination of sterile drug products are not established, written, and followed. Specifically, the [REDACTED] used for finished product sterilization during aseptic processing has not been qualified to ensure adequate [REDACTED] and [REDACTED]. Verification studies from 4/17-18/13 did not sufficiently validate the sterilization process, as the current procedure (SOP 8.010, v1) requires [REDACTED].

**Observation 3** points out that personnel clothing is inappropriate for duties. The gowning procedure for sterile product processing does not require sterile gowning, which could lead to microbial transmission from personnel into sterile