1Process validation
Time limits are not established when appropriate for the completion of each production phase to assure the quality of the drug product.
Inspection Record
Medaus Inc. — FDA 483 Findings
Inspectors Claire M. Minden · Jennifer Del ValleThe 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 monitoring environmental conditions.
3Aseptic 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.
4Stability and storage
Drug products are not stored under appropriate conditions of temperature and light so their identity, strength, quality and purity are not affected.
5Aseptic processing and sterility assurance
Each batch of drug product purporting to be sterile and pyrogen-free is not laboratory tested to determine conformance to such requirements.
6Stability and storage
There is no written testing program designed to assess the stability characteristics of drug products.
7Training and personnel
Clothing of personnel engaged in the of drug products is not appropriate for the duties they perform.
8Equipment and facility
Buildings used in the manufacture, processing, packing, or holding of a drug product do not have the suitabl e construction to facilitate cleaning, maintenance, and proper operations.
9Aseptic processing and sterility assurance
Aseptic processing areas are deficient regarding the system for cleaning and disinfecting to produce 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.
