USFDA 483 to Catalent Indiana Cites Poor Aseptic Practices, Equipment Maintenance

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

USFDA issued a Form 483 to Catalent Indiana facility (FEI: 3005949964) following an inspection by FDA investigators Wayne E Seifert, Hyung Yul Lee, Esther C Broner in May 2023. The Form 483 cited major deviations in aseptic practices and process controls, cleaning and maintenance of equipment.

Observation 1:

Poor Aseptic Practices, Processes

• Poor aseptic techniques: procedures for sanitisation of gloved hands not adhered to during setup of Fill line stopper bowl, transferring stopper bowl from Grade C to Grade A area, complete removal of stopper bowl covering in Grade A area, technician interrupting air, expose face skin directly over stopper bowl while assembling. Aseptic procedures not followed while dislodging stopper jam.
• Integrity testing, review and sterility assurance were inadequate before batch release.
• As per SOP after a non-confirming aseptic event, the employee shall receive feedback at the time of incident and meet with Manager of classified area or member of QC Microbiology management prior to entering classified area and conversation should be documented. This was not followed after multiple non-conforming aseptic events
• 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
• Aseptic Process Simulation Policy does not address sterile equipment and component hold time requirement and frequency; frequency not supported by risk assessment

Observation 2:

Sterilisation of Equipment

Equipment revalidation is inadequate for assurance that validated state is maintained

Observation 3:

Equipment Cleaning and Maintenance

The FDA investigators observed equipment, and facilities were not adequately maintained or cleaned. The lapses included a filter with dents and integrity of the filter not known, analytical balance in a manufacturing suite in a deteriorated state, tape peeling from a wall surface, discolouration in ceiling HEPA filter, cart with rusty wheel, inadequate door seal on a material movement control (MMC) receiving dock.

USFDA 483: Catalent Indiana, Bloomington, May 2023

Tags : Aseptic operation, Cleaning & Maintenance, Esther C Broner, Hyung Yul Lee, Sterile process controls, Sterility, USFDA 483, Wayne E Seifert
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