Aseptic Technique

Microbiology FDA 483 (Central Admixture Pharmacy): Aseptic processing areas are deficient for monitoring environmental conditions

Your aseptic operators disinfect ISO 5 surfaces prior to environmental monitoring sample collection. This practice can yield false-negative results. For

02/03/2024

Microbiology FDA 483 (Central Admixture Pharmacy): Procedures are not established, written and followed to prevent microbiological contamination

Your ISO 5 aseptic operators failed to demonstrate adequate aseptic technique. For example:

On July 11, 2023, two (2) of

29/02/2024

Microbiology FDA 483 (Kilitch Healthcare): Buildings used in the manufacture of drug products are not maintained in a clean and sanitary condition

On October 13, 2023 it was observed during a production area walkthrough that the *** floor in the Grade B

25/02/2024

Microbiology FDA 483 (Kilitch Healthcare): Aseptic processing areas are deficient for cleaning and disinfecting

(1) There is no assurance an effective sporicidal is used in the aseptic filling areas. *** *** is done with

25/02/2024

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 (Kilitch Healthcare): Procedures are not established, written and followed to prevent microbiological contamination

Specifically, during setup, aseptic filling, transfer of equipment and components, and line disassembly/cleaning in the Grade A area of ***

23/02/2024

Microbiology FDA 483 (Empower Clinic Services) : Inadequate routine environmental monitoring in the ISO 5 area and classified areas

pecifically, during a review of your firm’s environmental sampling results for your firm’s ISO 5 classified areas and equipment, we

20/02/2024

Microbiology FDA 483 (Empower Clinic Services) : Failure to clean and disinfect or sterilize equipment located in the ISO 5 area

Specifically, your firm’s *** management reported it has no data to ensure clean/deactivation reagents and methods used within the ISO

19/02/2024

Microbiology FDA 483 (Empower Clinic Services) : Personnel infrequently changed and sanitized gloves to prevent contamination

n 10/23/2023, during observation of your firm’s automated vial filling operation within your firm’s ISO 5 Cleanroom, for the drug

19/02/2024

Microbiology FDA 483 (Empower Clinic Services) : Aseptic manipulations where the movement of first air in the ISO 5 area is blocked or disrupted

Specifically, on 11/13/2023, during a review of selected *** aseptically sterile lots that were produced within your firm’s Formulation Room

19/02/2024

Microbiology FDA 483 (Central Admixture Pharmacy): Aseptic processing areas are deficient for monitoring environmental conditions

Microbiology FDA 483 (Central Admixture Pharmacy): Procedures are not established, written and followed to prevent microbiological contamination

Microbiology FDA 483 (Kilitch Healthcare): Buildings used in the manufacture of drug products are not maintained in a clean and sanitary condition

Microbiology FDA 483 (Kilitch Healthcare): Aseptic processing areas are deficient for cleaning and disinfecting

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

Microbiology FDA 483 (Kilitch Healthcare): Procedures are not established, written and followed to prevent microbiological contamination

Microbiology FDA 483 (Empower Clinic Services) : Inadequate routine environmental monitoring in the ISO 5 area and classified areas

Microbiology FDA 483 (Empower Clinic Services) : Failure to clean and disinfect or sterilize equipment located in the ISO 5 area

Microbiology FDA 483 (Empower Clinic Services) : Personnel infrequently changed and sanitized gloves to prevent contamination

Microbiology FDA 483 (Empower Clinic Services) : Aseptic manipulations where the movement of first air in the ISO 5 area is blocked or disrupted

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 (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 (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 (Sentara Enterprises): Personnel performed aseptic manipulations with exposed hair or skin

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