1Equipment and facility
Equipment and utensils are not cleaned, maintained, and sanitized at appropriate intervals to prevent contamination that would alter the safety, identity, strength, quality or purity of the drug product.
Inspection Record
Montana Compounding Pharmacy and Wellness Center — FDA 483 Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Material and supplier control
Components for drug product manufacturing are not weighed as appropriate.
3Aseptic processing and sterility assurance
Aseptic processing areas are deficient regarding the system for monitoring environmental conditions.
4Documentation and records
Batch production and control records do not include dates ofeach significant step in the manufacture and processing ofthe batch for each batch ofdrug product produced.
5Equipment and facility
Buildings used in the manufacture, processing, packing or holding ofdrug products are not maintained in a clean and sanitary condition.
6Aseptic processing and sterility assurance
Aseptic processing areas are deficient regarding air supply that is filtered through high-efficiency particulate air filters under positive pressure.
7Contamination control
Protective apparel is not worn as necessary to protect drug products from contamination.
8Stability and storage
There is no written testing program designed to assess the stability characteristics ofdrug products.
9Documentation and records
Batch production and control records do not include complete information relating to the production and control of each batch.
10Equipment and facility
Routine calibration ofmechanical equipment is not performed according to a written program designed to assure proper performance.
11Aseptic processing and sterility assurance
O Test procedures relative to appropriate laboratory testing for sterility and pyrogens are not written.
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.
