RXQ Compounding LLC – FDA 483, Aug 8, 2017

The FDA Form 483 inspection revealed numerous deficiencies in the facility's drug manufacturing operations. Key issues include the absence of established time limits for production phases to ensure drug quality and a failure to consistently meet sterilization parameters, as seen with Methylprednisolone Acetate 40 mg/ml injection suspension lot 04252017@1. Sterilization parameters were verbally stated by the QA Head but not documented in a procedure.

Product release procedures are inadequate, lacking appropriate laboratory determination of identity and strength for active ingredients. Procedures to prevent microbiological contamination of sterile drug products are not written or followed. Multiple instances of poor aseptic technique were observed on 7/11/2017, including an operator leaning against a wall in an ISO 8 cleanroom with a sterile gown, picking up trash with sterile gloves without changing them (Glutathione 200mg/ml, lot 07112017@1), and cross-contamination risks during Hydroxocobalamin 100 mcg/ml production (lot 07112017@3) where a sterile-gowned operator interacted with non-sterile personnel without changing gloves or gowning. Operators were also observed wiping goggles with sterile gloves and failing to remove outer foil layers from vials before entering the cleanroom.

Batch production records are deficient, lacking documentation of significant processing steps. Sterilization cycle printouts were not generated for