1Aseptic processing and sterility assurance
Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the room and equipment to produce aseptic conditions.
Inspection Record
Lincare, Inc. — FDA 483 Findings
Inspectors Matthew R. Maddox · Shelby N. Marler · Latorie S. JonesThe inspectors who signed the published document.Inspector lookup
View the regulator's official source The source document is always the basis for judgement.
Findings
2Equipment and facility
The building lacks adequate space for the orderly placement of equipment and materials to prevent mix-ups between different components, drug product containers, closures, and drug products and to prevent contam.ination.
3Aseptic processing and sterility assurance
Aseptic processing areas are deficient regarding the system for monitoring environmental conditions.
4Aseptic processing and sterility assurance
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not established, written, and followed.
5Training and personnel
Clothing of personnel engaged in the manufacturing and processing of drug products is not appropriate for the duties they perfo rm .
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.
