Procedure

Microbiology FDA 483 (Catalent Indiana): Laboratory controls do not include the establishment of scientifically sound and appropriate test procedures

Specifically, there is a failure to validate the endotoxin sample storage of drug products under project code *** at ***

23/03/2024

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 not followed for Enumeration of Microbial Colonies

Your firm failed to follow SOP HO-CQA-SOP-072, Enumeration of Microbial Colonies. On February 19 2024, while reviewing the personnel monitoring

21/03/2024

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 (Eugia SEZ): Equipment is not suitably located to facilitate operations for its intended use

Your film’s No. 04 Continuous Nonviable Pa1ticle Counter (NVPC), located near the *** conveyor area of *** Line *** is

21/03/2024

Microbiology FDA 483 (Central Admixture Pharmacy): Appropriate controls are not established for Computer System

On Jul 26, 2023, observed a Microbiology technician use another technician’s sign in for the *** Particulate Matter system to

03/03/2024

Microbiology FDA 483 (Central Admixture Pharmacy): Buildings used for drug products are not maintained in a clean and sanitary condition

On July 11, 2023, during the walk-through observed broken wooden pallets used to store drug product components in the receiving

03/03/2024

Microbiology FDA 483 (Central Admixture Pharmacy): Aseptic processing areas are deficient for maintaining equipment used to control the aseptic conditions

Specifically, on July 16, 2023, observed the following during the *** cleaning:

(A) Rust on the stainless-steel pole that held

02/03/2024

Microbiology FDA 483 (Central Admixture Pharmacy): Aseptic processing areas are deficient for cleaning and disinfection

Brown substance was observed inside your grey reusable spray bottles filled with the *** solution. On July 11, 2023, observed

02/03/2024

Microbiology FDA 483 (Central Admixture Pharmacy): Aseptic processing areas are deficient for monitoring environmental conditions

Your aseptic operators disinfect ISO 5 surfaces prior to environmental monitoring sample collection. This practice can yield false-negative results. For

02/03/2024

Microbiology FDA 483 (Catalent Indiana): Laboratory controls do not include the establishment of scientifically sound and appropriate test procedures

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 not followed for Enumeration of Microbial Colonies

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

Microbiology FDA 483 (Eugia SEZ): Equipment is not suitably located to facilitate operations for its intended use

Microbiology FDA 483 (Central Admixture Pharmacy): Appropriate controls are not established for Computer System

Microbiology FDA 483 (Central Admixture Pharmacy): Buildings used for drug products are not maintained in a clean and sanitary condition

Microbiology FDA 483 (Central Admixture Pharmacy): Aseptic processing areas are deficient for maintaining equipment used to control the aseptic conditions

Microbiology FDA 483 (Central Admixture Pharmacy): Aseptic processing areas are deficient for cleaning and disinfection

Microbiology FDA 483 (Central Admixture Pharmacy): Aseptic processing areas are deficient for monitoring environmental 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