1Contamination control
The separate or defined areas necessary to prevent contamination or mix-ups are deficient.
Inspection Record
Option Care Enterprises Inc. — FDA 483 Findings
Inspectors Sungeeta Mund Khurana · Bernard DeLeonThe 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
Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the room and equipment to produce aseptic conditions.
3Other quality system
The drug product is not identified with a lot or control number that permits the determination of the history of the manufacture and control of the batch.
4Aseptic processing and sterility assurance
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not followed.
5Aseptic processing and sterility assurance
Each batch of drug product purporting to be sterile is not laboratory tested to determine conformance to such requirements.
6Training and personnel
Clothing of personnel engaged in the manufacturing and processing of drug products is not appropriate for the duties they perform.
About this record
Extracted automatically from the document US FDA published on 2024-01-17. 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.
