Validation

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

Surface sampling locations within the ISO-5 areas for processing human and animal drug are not supported with appropriate studies.

03/04/2024

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

Investigations are not always performed for environmental / personnel monitoring excursions within the ISO-5 and ISO-7 (action limits of ***

03/04/2024

Microbiology FDA 483 (Biocon Sdn.): Fails to establish and document the accuracy, sensitivity, specificity, and reproducibility of its test methods

Specifically, *** stoppers are being used for product contact container-closures for *** vial and ***. However, your firm’s *** for

01/04/2024

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

Specifically, your firm has no written procedures on what corrective actions are to be performed when aseptic areas have a

31/03/2024

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): Smoke studies were inadequately performed under dynamic conditions

Unidirectional airflow was not verified under dynamic operational conditions representative of your aseptic processing practices. Air visualization studies (“smoke studies”)

29/03/2024

Microbiology FDA 483 (Sentara Enterprises): Smoke studies were inadequately performed under dynamic conditions

Specifically, unidirectional airflow was not verified under dynamic conditions representative of your typical production process. Smoke studies conducted in May

28/03/2024

Microbiology FDA 483 (Sentara Enterprises): Failure to conduct media fills under the worst-case, most-challenging, and stressful conditions

Specifically, your media fills do not include representative container-closure types (elastomeric pumps and large IV bags), equipment *** automated compounding

28/03/2024

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 (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 (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

Microbiology FDA 483 (Boothwyn Pharmacy): Smoke studies were inadequately performed under dynamic conditions

Microbiology FDA 483 (Sentara Enterprises): Smoke studies were inadequately performed under dynamic conditions

Microbiology FDA 483 (Sentara Enterprises): Failure to conduct media fills under the worst-case, most-challenging, and stressful conditions

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

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

Microbiology FDA 483 (Sun Pharmaceutical): Equipment and utensils are not cleaned and maintained at appropriate intervals to prevent contamination