Clean Room Practices

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 (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): 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): Equipment used is not of appropriate design and suitably located

Specifically, inside the aseptic area used in the manufacture of *** Injection, ***mg/vial, a box (approximately ****), is outlined on

11/03/2024

Microbiology FDA 483 (Panacea Biotec): Responsibilities and procedures applicable to the quality control unit are not in writing and fully followed

Specifically, Quality oversight is inadequate in that the aseptic processing areas are not designed to permit viewing through windows to

11/03/2024

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 (Panacea Biotec): Failure to thoroughly review any unexplained discrepancy to meet any of its specifications

Specifically, non-viable monitoring excursions obtained during machine parts assembly of more than *** or *** successive events within *** were

11/03/2024

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 (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): Written production and process control procedures are not followed, established. or are deficient

Microbiology FDA 483 (Panacea Biotec): Equipment used is not of appropriate design and suitably located

Microbiology FDA 483 (Panacea Biotec): Responsibilities and procedures applicable to the quality control unit are not in writing and fully followed

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 (Panacea Biotec): Failure to thoroughly review any unexplained discrepancy to meet any of its specifications

Microbiology FDA 483 (Eugia Pharma Specialities): Procedures to prevent microbiological contamination sterile drug product are not established and followed

Microbiology FDA 483 (Zydus Lifesciences): Appropriate controls are not exercised over computers or related systems

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

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

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

Microbiology FDA 483 (Zydus Lifesciences): Established sampling plans and test procedures are not followed

Microbiology FDA 483 (Precision Equine LLC): Equipment and utensils are not cleaned, maintained and sanitized at appropriate intervals to prevent malfunctions and contamination

Microbiology FDA 483 (Precision Equine LLC): Procedures to prevent microbiological contamination are not established; written and followed

Microbiology FDA 483 (Precision Equine LLC): No written testing program designed to assess the stability characteristics of drug products

Microbiology FDA 483 (Sun Pharmaceutical): The responsibilities and procedures applicable to the quality control unit are not in writing and fully followed