Aseptic Technique

Microbiology FDA 483 (Sentara Enterprises): Lack of disinfection of supplies at each transition from areas of lower quality air to areas of higher quality air

Specifically, on July 11, 2023, while Technician *** was observed working in ISO 5 classified *** laminar airflow hood s,

28/03/2024

Microbiology FDA 483 (Sentara Enterprises): Personnel performed aseptic manipulations with exposed hair or skin

Specifically, on July 11, 2023, while Technician *** was working in ISO 5 classified *** laminar airflow hood (equipment ID),

28/03/2024

Microbiology FDA 483 (Sentara Enterprises): The movement of first air in the ISO 5 area is blocked or disrupted

Specifically, on July 11, 2023 while Technician *** was working in ISO 5 classified *** Laminar airflow hood (equipment ID

28/03/2024

Microbiology FDA 483 (Front Door Pharmacy): Blocked the movement of first pass air by personnel conducting aseptic manipulations

Specifically, during the visual sterile production observation of the finished sterile drug product, P105 (PAP30MG/ PHE1MG/ PGE10MCG), Lot # 051321@***,

25/03/2024

Microbiology FDA 483 (Catalent Indiana): Procedures to prevent microbiological contamination did not include adequate validation of the aseptic process

The designs of Vial Line *** systems ( ***), Vial Line *** (System ***), Flexible Fill Line *** (System ***),

23/03/2024

Microbiology FDA 483 (Eugia SEZ): Procedures designed to prevent microbiological contamination are not followed

Your firm failed to follow EP4-PR-SOP-042, “Guidelines for Working in Aseptic Area” and EP4-MB-SOP-028, “Viable Monitoring Program”. The following are

21/03/2024

Microbiology FDA 483 (Samsung Biologics): Controls over manufacturing operations and process have not been adequately established

Airflow visualization studies have not been performed for all interventions as required by procedure: SOP-MFP-00206, “Airflow Visualization Evaluation”, Version; 8,0,

13/03/2024

Microbiology FDA 483 (Samsung Biologics): Written production and process control procedures are not followed, established. or are deficient

On 25 August 2023, observed for plant *** RABS Fill Line *** Batch #*** was the transition of the ***

12/03/2024

Microbiology FDA 483 (Panacea Biotec): Laboratory controls do not include the establishment of scientifically sound and appropriate specifications & standards

Your firm does not perform supplemental destructive testing to ensure the products are essentially free of visible particulates for ***

11/03/2024

Microbiology FDA 483 (Panacea Biotec): Procedures for the cleaning and maintenance of equipment are deficient

Specifically, cleaning procedures for the cleaning of *** RAB/RAB and the aseptic area do not contain enough detail to ensure

11/03/2024

Microbiology FDA 483 (Sentara Enterprises): Lack of disinfection of supplies at each transition from areas of lower quality air to areas of higher quality air

Microbiology FDA 483 (Sentara Enterprises): Personnel performed aseptic manipulations with exposed hair or skin

Microbiology FDA 483 (Sentara Enterprises): The movement of first air in the ISO 5 area is blocked or disrupted

Microbiology FDA 483 (Front Door Pharmacy): Blocked the movement of first pass air by personnel conducting aseptic manipulations

Microbiology FDA 483 (Catalent Indiana): Procedures to prevent microbiological contamination did not include adequate validation of the aseptic process

Microbiology FDA 483 (Eugia SEZ): Procedures designed to prevent microbiological contamination are not followed

Microbiology FDA 483 (Samsung Biologics): Controls over manufacturing operations and process have not been adequately established

Microbiology FDA 483 (Samsung Biologics): Written production and process control procedures are not followed, established. or are deficient

Microbiology FDA 483 (Panacea Biotec): Laboratory controls do not include the establishment of scientifically sound and appropriate specifications & standards

Microbiology FDA 483 (Panacea Biotec): Procedures for the cleaning and maintenance of equipment are deficient

Microbiology FDA 483 (Sun Pharmaceutical): Equipment and utensils are not cleaned and maintained at appropriate intervals to prevent contamination

Microbiology FDA 483 (Eugia Steriles): Control procedures are not established which validate the performance of those manufacturing processes

Microbiology FDA 483 (Eugia Steriles): Input to and output from the computer and records or data are not checked for accuracy

Microbiology FDA 483 (Eugia Steriles): Procedures to prevent microbiological contamination are not established and followed

Microbiology FDA 483 (Zydus Lifesciences): Equipment and utensils are not cleaned and maintained at appropriate intervals to prevent contamination

Microbiology FDA 483 (Zydus Lifesciences): Buildings used in the manufacturing of a drug product are not maintained in a good state of repair

Microbiology FDA 483 (Zydus Lifesciences): Procedures designed to prevent microbiological contamination are not written and followed

Microbiology FDA 483 (Zydus Lifesciences): Aseptic processing areas are deficient regarding the system for monitoring environmental conditions

Microbiology FDA 483 (Cipla Limited): Failure to clean and maintain equipment and utensils to prevent contamination

Microbiology FDA 483 (Alkem Laboratories): Laboratory controls do not include the establishment of scientifically sound and appropriate specifications, standards, test procedures