1Training and personnel
Personnel donned gowning apparel improperly, in a way that may have caused the gowning apparel to become contaminated.
Inspection Record
TMC Acquisition LLC dba Tailor Made Compounding — FDA 483 Findings
Inspectors Lauren N. Howard · Lisa R. Hilliard · Logan T. WilliamsThe inspectors who signed the published document.Inspector lookup
View the regulator's official source The source document is always the basis for judgement.
Findings
2Contamination control
Non-microbial contamination was observed in your production area.
3Validation and qualification
ISO 5 classified areas were not adequately certified under dynamic conditions to demonstrate unidirectional airflow.
4Equipment and facility
Your facility was designed and/or operated in a way that permits poor flow of personnel and materials.
5Aseptic processing and sterility assurance
You had inadequate HEPA filter coverage over the area to which sterile product was exposed.
6Aseptic processing and sterility assurance
Environmental monitoting was not perfonned in your aseptic processing areas.
7Contamination control
You produced hazardous drugs without providing adequate cleaning of utensils to prevent cross-contamination.
8Material and supplier control
You used a non-pharmaceutical grade component in the formuation a drug product.
9Aseptic processing and sterility assurance
Personnel conducted aseptic manipulations in an area that blocked the movement of first pass air around an open unit, either before or after it was filled with sterile product.
10Aseptic processing and sterility assurance
Media fills are not performed that closely simulate aseptic production operations incorporating, as appropriate, worst-case activities and conditions that provide a challenge to aseptic operations.
11Training and personnel
Personnel manually contacted the inner surface of the container or closure.
12Equipment and facility
Your facility design allowed the influx of poor quality air into a higher classified area.
13Aseptic processing and sterility assurance
Materials or supplies were not disinfected prior to entering the aseptic processing areas.
About this record
Extracted automatically from the document US FDA published on 2022-10-28. The source is available at the link above.
This is a record of that moment. Inspection findings are usually followed by the company's response and corrective action, but this page does not know how that turned out. Do not read it as the current state; check the regulator's official announcements for the latest status.
Translation and classification are automated and may differ in nuance from the source.
