FDA 483 - Crosbys Drugs Inc - September 30, 2021

This FDA Form 483 documents observations from an inspection of a facility involved in sterile drug product compounding.

**Key Violations and Observations:**

* **Sterility Testing Deficiencies:** * Failure to conduct (b)(4) testing on (b)(4) used for sterilization. An operator was observed discarding a used (b)(4) without testing, and the Director of Pharmacy retrieved it for later testing. * No (b)(4) testing performed for Papaverine/Phentolamine/Alprostadil lot 09142021@11. * Lack of documentation for (b)(4) testing on lots 09022021@7, 09102021@1, 08192021@10, indicating it was likely not done.

* **Aseptic Processing and Environmental Control:** * Media fills did not closely simulate aseptic production under worst-case/challenging conditions, failing to account for continuous compounding. * Non-sterilized, non-depyrogenated equipment used: A depyrogenated, foil-wrapped beaker was unwrapped outside the ISO 5 hood and used for weighing/mixing, exposing it to less than ISO 5 air. * No data to confirm depyrogenation procedures for glassware are followed