Cleaning and Sanitization

Microbiology FDA 483 (Barclay, Luke & Pillai Specialty Pharmacy): Non microbial contamination was observed in your production area

Your sterile non-hazardous and sterile hazardous cleanrooms, both of which are used to produce drug products purported to be sterile,

05/03/2024

Microbiology FDA 483 (Barclay, Luke & Pillai Specialty Pharmacy): Aseptic processing areas had visibly dirty equipment or surface

The ISO 5 hoods in your sterile non-hazardous cleanroom, both of which are used to produce drug products purported to

05/03/2024

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 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 (Dr. Reddy’s Laboratories): Equipment and utensils are not cleaned and maintained at appropriate intervals to prevent contamination

Specifically, major production equipment used to manufacture *** dosage drug products is not appropriately cleaned and maintained to prevent contamination.

26/02/2024

Microbiology FDA 483 (Kilitch Healthcare): Aseptic processing areas are deficient for cleaning and disinfecting

(1) There is no assurance an effective sporicidal is used in the aseptic filling areas. *** *** is done with

25/02/2024

Microbiology FDA 483 (Empower Clinic Services) : Failure to clean and disinfect or sterilize equipment located in the ISO 5 area

Specifically, your firm’s *** management reported it has no data to ensure clean/deactivation reagents and methods used within the ISO

19/02/2024

Microbiology FDA 483 : Lack of assurance of manufacturing operations – prevention of contamination of equipment or product by environmental and processing conditions

12/02/2024

Microbiology FDA 483 : firm’s quality unit’s oversight of your GMP manufacturing operations is inadequate

Your firm’s quality unit’s oversight of your GMP manufacturing operations is inadequate, Service Vendor Audit

09/02/2024

Microbiology FDA 483 (Barclay, Luke & Pillai Specialty Pharmacy): Non microbial contamination was observed in your production area

Microbiology FDA 483 (Barclay, Luke & Pillai Specialty Pharmacy): Aseptic processing areas had visibly dirty equipment or surface

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 cleaning and disinfection

Microbiology FDA 483 (Dr. Reddy’s Laboratories): Equipment and utensils are not cleaned and maintained at appropriate intervals to prevent contamination

Microbiology FDA 483 (Kilitch Healthcare): Aseptic processing areas are deficient for cleaning and disinfecting

Microbiology FDA 483 (Empower Clinic Services) : Failure to clean and disinfect or sterilize equipment located in the ISO 5 area

Microbiology FDA 483 : Lack of assurance of manufacturing operations – prevention of contamination of equipment or product by environmental and processing conditions

Microbiology FDA 483 : firm’s quality unit’s oversight of your GMP manufacturing operations is inadequate

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