1Aseptic processing and sterility assurance
The use of sporicidal agents in the cleanrooms and ISO 5 classified aseptic processing area was inadequate.
Inspection Record
Boothwyn Pharmacy LLC — FDA 483 Findings
Inspectors Sena G Dissmeyer · Tanya R SyffrardThe inspectors who signed the published document.Inspector lookup
View the regulator's official source The source document is always the basis for judgement.
Findings
2Aseptic processing and sterility assurance
Your media fills were not performed under the most challenging or stressful conditions.
3Aseptic processing and sterility assurance
Equipment was and Materials or supplies were not disinfected prior to entering the aseptic processing areas.
4Training and personnel
Personnel sampling was conducted after gloves had been cleaned/disinfected.
5Equipment and facility
Your facility failed to confirm that the quality of water was suitable for its intended use in the production of non-sterile drug products.
6Validation and qualification
1SO-5 classified areas were not certified under dynamic conditions.
7Aseptic processing and sterility assurance
Personnel conducted aseptic manipulations and placed equipment/supplies 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.
8Contamination control
You produced hazardous drugs without providing adequate containment, segregation, cleaning of work smfaces, cleaning of utensils and cleaning ofpersonnel to prevent cross-contamination.
9Aseptic processing and sterility assurance
The ISO 5 classified aseptic processing areas had difficult to clean, particle-generating and visibly dirty equipment or surface.
About this record
Extracted automatically from the document US FDA published on 2024-02-29. 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.
