1Aseptic processing and sterility assurance
Disinfecting agents and cleaning pads or wipes used in the ISO 5 aseptic processing are not sterile.
Inspection Record
Abilene Nuclear LLC dba National Central Pharmacy — FDA 483 Findings
Inspectors Camerson E MooreThe 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
Media fills were not performed that closely simulate aseptic production operations incorporating, as appropriate, worse-case activities and conditions that provide a challenge to aseptic operations.
3Documentation and records
The batch production and control records are deficient in that they do not include identification of persons performing and checking each significant step in the operation.
4Aseptic processing and sterility assurance
Materials or supplies were not disinfected prior to entering the aseptic processing areas.
5Aseptic processing and sterility assurance
Personnel touched equipment or other surfaces located outside of the ISO 5 classified aseptic processing area with gloved hands and then engaged in aseptic processing without changing or sanitizing gloves.
6Aseptic processing and sterility assurance
Personnel engaging in aseptic processing was observed with exposed skin.
7Equipment and facility
The facility design was observed to allow the influx of poor quality air into a higher classified area.
8Aseptic processing and sterility assurance
Personnel 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.
About this record
Extracted automatically from the document US FDA published on 2020-01-07. 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.
