1Laboratory and QC controls
Each batch of drug product required to be free ofobjectionable microorganisms is not tested through appropriate laboratory testing.
Inspection Record
The Compounding Shop — FDA 483 Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Equipment and facility
Routine calibration of mechanical and clectronic equipment is not performed according to a written program designed to assure proper performance.
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 do not include adequate validation of the sterilization process.
5Stability and storage
There is no written testing program designed to assess the stability characteristics ofdrug products.
6Equipment and facility
Equipment and utensils are not maintained at appropriate intervals to prevent contamination that would alter the safery, identity, strength, quality or purity ofthe drug product.
7Aseptic processing and sterility assurance
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not established, written, and followed.
8Training and personnel
Clothing of personnel engaged in the manufacturing and processing ofdrug products is not appropriate for the duties they perform.
9Laboratory and QC controls
Testing and release ofdrug product for distribution do not include appropriate laboratory determination ofsatisfactory conformance to the final specifications and identity and strength of each active ingredient prior to release.
10Aseptic processing and sterility assurance
There are no written standards or specifications, methods of testing, methods of cleaning, and methods of sterilization to remove pyrogenic properties.
11Aseptic processing and sterility assurance
Aseptic processing areas arc deficient regarding the system for cleaning and disinfecting the room and equipment to produce aseptic conditions.
12Equipment and facility
Ascptic processing areas are deficient regarding air supply that is filtered through high-efficiency particulate air filters under positive pressure.
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.
