Disinfection

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

Surface monitoring of the filling and stoppering machine is not performed in a timely manner following the completion of aseptic

22/05/2024

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

On April 29, 2024, *** cleaning wipes packed and ready to be used for *** aseptic cleaning in the Grade

22/05/2024

Microbiology FDA 483 (Wedgewood Connect): Aseptic areas are deficient for cleaning and disinfecting the room and equipment to produce aseptic conditions

Specifically, disinfectant efficacy studies have not been performed for the ***, and the *** cleaning solutions used within your IS0-5

02/04/2024

Microbiology FDA 483 (Biocon Sdn.): Procedures to prevent microbiological contamination are not established, written, or followed

On 07/10/2023 and 07/12/2023, inspected the post assembly and/ or aseptic filling of *** mL batch *** respectively. Observed the

30/03/2024

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 (Sentara Enterprises): Lack of disinfection of supplies at each transition from areas of lower quality air to areas of higher quality air

Specifically, on July 11, 2023, while Technician *** was observed working in ISO 5 classified *** laminar airflow hood s,

28/03/2024

Microbiology FDA 483 (Front Door Pharmacy): The use of sporicidal agents in aseptic processing area was inadequate

Specifically, your firm failed to validate the sporicidal agent, *** Sporicidal Disinfectant Cleaner for its intended use within the cleanroom

26/03/2024

Microbiology FDA 483 (Stokes Healthcare): Aseptic processing areas are deficient for cleaning and disinfecting to produce aseptic conditions

Your firm has not conducted smoke studies nor media fills under dynamic conditions in rooms C704, and C706 where filling

24/03/2024

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 (Wedgewood Connect): Aseptic areas are deficient for cleaning and disinfecting the room and equipment to produce aseptic conditions

Microbiology FDA 483 (Biocon Sdn.): Procedures to prevent microbiological contamination are not established, written, or 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 (Sentara Enterprises): Lack of disinfection of supplies at each transition from areas of lower quality air to areas of higher quality air

Microbiology FDA 483 (Front Door Pharmacy): The use of sporicidal agents in aseptic processing area was inadequate

Microbiology FDA 483 (Stokes Healthcare): Aseptic processing areas are deficient for cleaning and disinfecting to produce aseptic conditions

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