Validation

Microbiology FDA 483 (Eugia SEZ): Aseptic processing areas are deficient for cleaning and disinfecting

There is no disinfectant efficacy study performed for *** tubing used for drug product transfer during vial filling on ***

22/03/2024

Microbiology FDA 483 (Eugia SEZ): Failure to maintain a backup file of data entered into the computer or related system

*** Nonviable Particle Counters, Model Number, 3423, Equipment ID No. PR-NVPCP-001, PRNWCP-002, PR-NVPCP-004, lack the functionality to save data internally

22/03/2024

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 (Samsung Biologics): Revalidation of equipment is not performed at appropriate intervals

Your firm’s Quality Unit failed to ensure equipment is maintained and used within its validated state. For example:

13/03/2024

Microbiology FDA 483 (Dr. Reddy’s Laboratories): The accuracy, sensitivity, specificity and reproducibility of test methods have not been established

Specifically, accuracy, sensitivity, specificity, and reproducibility of TAMC (Toral Aerobic Microbial Count) test used to routinely test *** for the

27/02/2024

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 (Empower Clinic Services) : Biological indicators were not used to verify the adequacy of the sterilization cycle

your firm fail to use biological indicators to ensure your firm’s glassware is endotoxin free by undergoing an adequate ***.

20/02/2024

Microbiology FDA 483 (Aurobindo/Eugia Pharma) : No adequate validation of the aseptic process to prevent microbiological contamination

(1) Block *** Line *** re-qualification and *** exposure were not adequately performed:

(a) During *** re-qualification, Chemical Indicators (CI)

17/02/2024

Microbiology FDA 483 (Eugia SEZ): Aseptic processing areas are deficient for cleaning and disinfecting

Microbiology FDA 483 (Eugia SEZ): Failure to maintain a backup file of data entered into the computer or related system

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

Microbiology FDA 483 (Samsung Biologics): Revalidation of equipment is not performed at appropriate intervals

Microbiology FDA 483 (Dr. Reddy’s Laboratories): The accuracy, sensitivity, specificity and reproducibility of test methods have not been established

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

Microbiology FDA 483 (Empower Clinic Services) : Biological indicators were not used to verify the adequacy of the sterilization cycle

Microbiology FDA 483 (Aurobindo/Eugia Pharma) : No adequate validation of the aseptic process to prevent microbiological contamination

Microbiology FDA 483 (Alkem Laboratories): Responsibilities and procedures applicable to the quality control unit are not in writing and fully

Microbiology FDA 483 (Jubilant Generics): The responsibilities and procedures applicable to the quality control unit are not in writing and fully followed

Microbiology FDA 483 (Contract Pharmaceuticals): Failure to thoroughly review any unexplained discrepancy

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 (Wedgewood Connect): Aseptic processing areas are deficient regarding the system for monitoring environmental conditions

Microbiology FDA 483 (Wedgewood Connect): Written records are not always made of investigations into unexplained discrepancies

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.): Fails to establish and document the accuracy, sensitivity, specificity, and reproducibility of its test methods

Microbiology FDA 483 (Biocon Sdn.): Failure to have written procedures for connective and preventative actions during loss or reversals of different pressure in classified aseptic areas

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