1Equipment and facility
Your facility was designed in a way that permits poor flow of personnel and materials.
Inspection Record
Crosbys Drugs Inc — FDA 483 Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Other quality system
Your firm failed to conduct <Redacted B4> testing on <Redacted B4> used to sterilize drug products.
3Training and personnel
Personnel donned gowning apparel improperly, in a way that may have caused the gowning apparel to have been contaminated.
4Aseptic processing and sterility assurance
Your firm failed to conduct media fills that closely simulate aseptic production operations under the worst-case, most-challenging and stressful conditions.
5Aseptic processing and sterility assurance
Non sterilized, non-depyrogenated equipment used in sterile drug production Specifically, i.
6Aseptic processing and sterility assurance
Personnel engaged in aseptic processing were observed leaving and re-entering the clean room without replacing the gowning apparel.
7Other quality system
Disinfectant contact time (also known as "dwell time") and coverage of the item being disinfected were insufficient to achieve adequate level of disinfection.
8Aseptic 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.
About this record
Extracted automatically from the document US FDA published on 2022-05-26. 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.
