Clean Room

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

During walk-through of the facility on 8/23/2023, contamination was observed in your sterile and non-sterile areas for the following:

Unknown

27/04/2024

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

Your firm does not properly clean and maintain ***-405 which is utilized in the manufacture of *** USP active pharmaceutical

12/04/2024

Microbiology FDA 483 (Wedgewood Connect): Procedures to prevent microbiological contamination of drug products purporting to be sterile are not established and followed

Requalification of the *** Sterilization Process for *** Loads *** Bottle Formats) in the *** Model ***, Equipment ID# E-0832-W,

03/04/2024

Microbiology FDA 483 (Boothwyn Pharmacy): Inadequate containment, segregation, and/or cleaning of work surfaces, utensils, and/or personnel to prevent cross-contamination

On August 9,2023 your technician (***) did not spray their gloves with a deactivating agent or change their gloves after

29/03/2024

Microbiology FDA 483 (Boothwyn Pharmacy): Use of a sporicidal agent in the facility’s ISO 5 areas and classified areas was improper

On August 18, 2023, your technician *** did not clean the ***, located *** the ISO 8 classified preparation room

29/03/2024

Microbiology FDA 483 (Boothwyn Pharmacy): Use of non-sterile cleaning wipes in the ISO 5 area

Specifically, your technicians were observed using *** wipes, during cleaning operations *** aseptic production which include cleaning of the hard

29/03/2024

Microbiology FDA 483 (Boothwyn Pharmacy): Influx of lesser quality air into a classified area containing higher quality air

Specifically, your non-hazardous drug preparation room, *** and your hazardous drug preparation room, *** share a vent which increases the

29/03/2024

Microbiology FDA 483 (Front Door Pharmacy): ISO-5 classified areas were not certified under dynamic conditions

Specifically, unidirectional airflow was not verified under operational conditions. Your firm’s clean room re certification reports tests dated 1/27/2021, 8/5/2020,

26/03/2024

Microbiology FDA 483 (Front Door Pharmacy): Facility design allowed the influx of poor-quality air into a higher classified area

Specifically, your firm air returns are adjacent to your HEPA filters in the ceiling of the ISO 8 Anteroom and

26/03/2024

Microbiology FDA 483 (Front Door Pharmacy): Environmental monitoring was not performed in your aseptic processing areas

Specifically, environmental Monitoring and measurement frequency of microbiological contamination (viable/non-viable monitoring) of the air in the ISO 5 zone is

26/03/2024

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

Microbiology FDA 483 (Wedgewood Connect): Procedures to prevent microbiological contamination of drug products purporting to be sterile are not established and followed

Microbiology FDA 483 (Boothwyn Pharmacy): Inadequate containment, segregation, and/or cleaning of work surfaces, utensils, and/or personnel to prevent cross-contamination

Microbiology FDA 483 (Boothwyn Pharmacy): Use of a sporicidal agent in the facility’s ISO 5 areas and classified areas was improper

Microbiology FDA 483 (Boothwyn Pharmacy): Use of non-sterile cleaning wipes in the ISO 5 area

Microbiology FDA 483 (Boothwyn Pharmacy): Influx of lesser quality air into a classified area containing higher quality air

Microbiology FDA 483 (Front Door Pharmacy): ISO-5 classified areas were not certified under dynamic conditions

Microbiology FDA 483 (Front Door Pharmacy): Facility design allowed the influx of poor-quality air into a higher classified area

Microbiology FDA 483 (Front Door Pharmacy): Environmental monitoring was not performed in your aseptic processing areas

Microbiology FDA 483 (Jiangsu Hengrui Pharmceuticals): Container closure systems do not provide adequate protection against foreseeable external factors

Microbiology FDA 483 (Jiangsu Hengrui Pharmceuticals): Procedures designed to prevent microbiological contamination of drug products purporting to be sterile did not include adequate validation of the aseptic and sterilization process

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

Microbiology FDA 483 (Jubilant Radiopharmacies): Personnel were observed performing aseptic processing outside of an ISO 5 area

Microbiology FDA 483 (Eugia Pharma Specialities): Aseptic processing areas are deficient regarding the system for monitoring environmental conditions

Microbiology FDA 483 (Eugia Pharma Specialities): Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the equipment to produce aseptic conditions

Microbiology FDA 483 (Eugia Pharma Specialities): Separate or defined areas to prevent contamination or mix-ups are deficient regarding the manufacturing and processing operations

Microbiology FDA 483 (Eugia Pharma Specialities): There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch or any of its components to meet any of its specifications whether or not the batch has been already distributed

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

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