USFDA 483 of Catalent, Bloomington, USA cites 3 observations pertaining to failure to follow / establish procedures and processes in Aseptic areas, Aseptic techniques, Inadequate Equipment revalidation and Cleaning and Maintenance after an audit in May 2023. Earlier Regeneron had announced FDA didn’t approve an 8 mg version of Eylea and issued a Complete Response (CR) letter after inspection at a third party filler Read More..

Catalent USFDA 483 /Bloomington (FEI :3005949964)/ Inspection Dates: May 4-12, 2023 / Inspectors: Wayne Scifert, Hyung-yul Lee, Esther C.Broner

Observation 1:

In the aseptic area, procedures and processes are not followed /established:

• Poor aseptic practices by technicians in sanitising gloved hands, moving stopper bowls, considering post manufacture integrity testing in batch release, failure to perform visual inspections after interventions in aseptic vial filling line, documentation of non conformance aseptic event.
• Gloved hands were not sanitised before machine set up of Flexible Fill stopper bowl
• Lack of good aseptic technique when moving stopper bowls from Grade C to Grade A area (Opening the cover in Grade A area, technician exposing uncovered face directly above the bowl in Grade A area, moving gloves directly above open containers)
• In flexible filling line, post manufacturing integrity testing is not performed for sterility assurance
• Periodic integrity testing is not considered in batch release. This was identified as a gap by the Firm in Nov 22, but CAPA due date was May 2023, not commensurate with the level of risk
• Failure to establish maximum clean hold time limit for fill line machine assembly
• Visual inspections are not performed after multiple interventions on the Vial Filling line
• Non-conformance aseptic event Form was not filled and feedback taken, after such events noted
• Periodic Qualification evaluation fails to include Sterile equipment and component hold time; not supported by risk assessment

Observation 2:

Equipment revalidation is inadequate in support of sterile manufacture.

Observation 3:

Equipment and facilities are not adequately maintained / cleaned-filter with dents, ceiling HEPA with discolouration, tape peeling from wall surface, floor below balance unclean.