Cleaning and Sanitization

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 (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 (Catalent Indiana): Procedures to prevent microbiological contamination did not include adequate validation of the aseptic process

The designs of Vial Line *** systems ( ***), Vial Line *** (System ***), Flexible Fill Line *** (System ***),

23/03/2024

Microbiology FDA 483 (Eugia SEZ): Lack the training required to perform assigned functions

The ability of visual inspectors to identify integrity defects during visual inspection of ** Restricted Access Barmier System *** RABS)

22/03/2024

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): 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 (Panacea Biotec): Procedures for the cleaning and maintenance of equipment are deficient

Specifically, cleaning procedures for the cleaning of *** RAB/RAB and the aseptic area do not contain enough detail to ensure

11/03/2024

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

Smoke studies are inadequate in that they do not demonstrate unidirectional air flow in the following instances

09/03/2024

Microbiology FDA 483 (Barclay, Luke & Pillai Specialty Pharmacy): Unsealed, loose ceiling tiles were observed in your cleanroom

On 11/28/22, an unsealed ceiling tile was observed directly above the ISO 5 biosafety cabinet (BSC) in your ISO 7

06/03/2024

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

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 (Catalent Indiana): Procedures to prevent microbiological contamination did not include adequate validation of the aseptic process

Microbiology FDA 483 (Eugia SEZ): Lack the training required to perform assigned functions

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

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

Microbiology FDA 483 (Panacea Biotec): Procedures for the cleaning and maintenance of equipment are deficient

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

Microbiology FDA 483 (Barclay, Luke & Pillai Specialty Pharmacy): Unsealed, loose ceiling tiles were observed in your cleanroom

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

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