1Aseptic processing and sterility assurance
As eptic proces ing areas are deficient regarding the system for monitoring environmental conditions.
Inspection Record
LeeSar, Inc. — FDA 483 Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Aseptic processing and sterility assurance
Procedures designed to prevent microbiological contamination of drug p roducts purporting to be sterile do not include validation of the sterilization p ro cess.
3Training and personnel
Clothing of personnel engaged in the manufacturing, processing, packing, and holding of drug products is not appropiate for the d ut ies they perform.
4Aseptic processing and sterility assurance
Aseptic processing areas are deficient regarding systems for maintaining and e quipment used to control the aseptic c onditions.
5Quality unit oversight
Each lot of components, drug product containers, and closures is not withheld from use until the lot has been sampled, tested, exam ined, and released by the quality control unit.
6Aseptic processing and sterility assurance
Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the room and equipment to produce a se ptic conditions.
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.
