USFDA 483 to Catalent Baltimore Flags Deficiencies in Aseptic Practices

An USFDA 483 to CDMO major Catalent’s Baltimore facility (FEI 3015558590) in US cite poor aseptic practices and inadequate maintenance of the facilities. The site manufactures biological drug products, including Delandistrogene Moxeparvovec (Elevidys), and was inspected by FDA investigator Lizaida Perez in April, 2025

Similar deficiencies were observed at Catalent’s Bloomington, Indiana site, where FDA inspectors noted “first air” violations in aseptic filling areas during an inspection in July,2025. That site was subsequently issued a Warning Letter in November 2025 for gross GMP deviations, including microbial contamination control failures and inadequate investigation of mammalian hair contamination in drug products.

Operators Failure to Follow Aseptic Techniques

Operators were observed to be not adhering to microbial contamination control procedures and aseptic behaviour during filling of the drug product Delandistrogene Moxeparvovec. During interventions requiring repeated opening and reaching into the RABS near the filling equipment:

• Glove (hand) sanitisation were not performed frequently
• Movements performed were rapid and not slow and deliberate in the aseptic filling suite

Maintenance of Buildings

• Aseptic filling area / floor was not maintained in a good state of repair

Microbial Contamination Controls in Sterile Products

Microbial contamination control is critical in manufacture of sterile drug products. Operators involved in the aseptic operations should be well trained, routinely monitored for aseptic practices and compliance to procedures. Facilities should be maintained in good condition with prompt redressal of any issues observed during operation. Improper aseptic behaviour and facility maintenance can directly impact product sterility and patient safety.

• USFDA 483 to Catalent Baltimore facility (April 2025)