Smoke studies

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 (Panacea Biotec): Procedures to prevent microbiological contamination did not include adequate validation of the aseptic process

Smoke studies are inadequate in that they do not demonstrate unidirectional air flow in the following instances

09/03/2024

Microbiology FDA 483 (Kilitch Healthcare): Procedures designed to prevent microbiological contamination not include adequate validation of the aseptic process

(1) Smoke studies do not show demonstrate appropriate airflow:

(a) Smoke studies for Line *** and Line *** show turbulent

24/02/2024

Microbiology FDA 483 : Smoke studies were inadequately performed under dynamic conditions

Smoke studies were inadequately performed under dynamic conditions

08/02/2024

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

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

Microbiology FDA 483 (Kilitch Healthcare): Procedures designed to prevent microbiological contamination not include adequate validation of the aseptic process

Microbiology FDA 483 : Smoke studies were inadequately performed under dynamic conditions

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