1Aseptic processing and sterility assurance
Disinfecting agents and cleaning wipes used in the ISO 5 classified aseptic processing areas were not sterile.
Inspection Record
Medical Center Pharmacy, Inc. — FDA 483 Findings
Inspectors Demario L. WallsThe 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
You had inadequate HEPA filter coverage and airflow over the area to which sterile product was exposed.
3Aseptic processing and sterility assurance
Parameters for sterilization are not lethal to resistant microorganisms.
4Aseptic processing and sterility assurance
fhe area adjacent to the ISO 5 classified aseptic processing areas had difficult to clean, particle-generating and visibly dirty equipment or surface.
5Aseptic processing and sterility assurance
Equipment and Materials or supplies were not disinfected prior to entering the aseptic processing areas.
6Contamination control
You produced hazardous drugs without providing adequate containment, segregation, cleaning of work surfaces, cleaning of utensils and cleaning of personnel to prevent cross-contamination.
7Aseptic processing and sterility assurance
Media fills are not conducted to simulate aseptic production operations that represent the most-challenging and stressful conditions Specifically, on 03/16/2020, your pharmacist-in-charge stated the largest batch size produced at your firm under aseptic operations is <Redacted B4>.
8Aseptic processing and sterility assurance
You did not make adequate product evaluation and take remedial action where microbial contamination iwas found to be present in the lSO 5 classified aseptic processing or areas surrounding the ISO 5 classified iarea.
9Aseptic processing and sterility assurance
Your aseptic processing conditions do not offer sufficient assurance that the finished product is sterile.
10Aseptic processing and sterility assurance
Your aseptic processing conditions do not offer sufficient assurance that the finished product will meet an endotoxin specification appropriate for its route of administration.
About this record
Extracted automatically from the document US FDA published on 2020-07-01. 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.
