Inspection Record

Lincare, Inc. — FDA 483 Findings

US FDAInspected 2015-07-23Published 2024-01-17 5 findingsEquipment and facilityAseptic processing and sterility assuranceTraining and personnel

Inspectors Shelby N. Marler · Matthew R. Maddox · 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

1Equipment 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 contamination.

2Aseptic processing and sterility assurance

Aseptic processing areas are deficient regarding the system for monitoring environmental conditions.

3Training and personnel

Clothing of personnel engaged in the manufacturing and processing of drug products is not appropriate for the duties they perform.

4Aseptic processing and sterility assurance

Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the room and equipment to produce aseptic conditions.

5Aseptic processing and sterility assurance

Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not established, written, and followed.

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.

Other records for this company

2015-07-23 · US FDA · 5 findings
Lincare, Inc. company profile — full history US FDA documents, 2024 Go to Findings search