FDA 483 - Fagron Compounding Services - June 21, 2019

This FDA Form 483 details multiple deficiencies at an unnamed facility compounding injectable drug products.

**Equipment and Maintenance:** * Laminar flow hoods (FSS-1050, FSS-1053) in aseptic processing areas had brown/black residue and cracked panels during active filling of Glycopyrolate and Succinylcholine Chloride.

**Testing and Release:** * Drug products containing preservatives (e.g., Succinylcholine Chloride, Neostigmine Methylsulfate, Glycopyrolate, Sodium Citrate, Ketamine) are not tested for preservative content at release or during stability studies.

**Personnel and Environment:** * Aseptic operators wore goggles with numerous holes in ISO 5 laminar flow hoods, compromising product protection. * Non-viable particle counters were improperly located, not in close proximity to aseptic operators, providing unrepresentative environmental monitoring data.

**Quality Control and Investigations:** * A Media Fill study (FSS 2018-030) lacked complete results, incubated unit information, and a final report. * Out-of-specification (OOS) investigations (e.g., Neostigmine, Rocuronium, Glycopyrolate, Sodium Thiosulfate) were incomplete, lacking full review of manufacturing processes as per SOP 1.040.FSS, and batches were released despite unresolved OOS results. *