1Aseptic processing and sterility assurance
Your firm failed to establish an adequate system for monitoring environmental conditions in aseptic processing areas.
Inspection Record
Kings Park Slope, Inc. — FDA 483 Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Other quality system
Containers and closmes are not tested for conformance with all appropriate written procedures.
3Aseptic processing and sterility assurance
Your firm failed to establish an adequate system for cleaning and disinfecting the room and equipment to produce aseptic conditions.
4Equipment and facility
Your firm failed to clean, maintain, and, as appropriate for the nature of the drug, sanitize and/or sterilize equipment and utensils at appropriate intervals to prevent malfunctions or contamination that would alter th e safety, identity, strength, quality, or purity of the drug product beyond the official or other establishe d requirements.
5Aseptic processing and sterility assurance
Your firm does not have, for each batch of drug product purporting to be sterile and/or pyrogen-free, appropriate laboratory determination of satisfactory conformance to final specifications for the drug product.
6Aseptic processing and sterility assurance
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile do not include validation of the sterilization process.
7Training and personnel
Clothing of personnel engaged in the processing of drug products is not appropriate for the duties they perform.
8Aseptic processing and sterility assurance
Your firm failed to establish an adequate system for maintaining equipment used to control the aseptic 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.
