1Stability and storage
There shall be a written testing program designed to assess the stability characteristics ofdrug products.
Inspection Record
Fallon Wellness Pharmacy, LLC. — FDA 483 Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Other quality system
Containers and closures are not reviewed for conformance with all appropriate written procedures.
3Contamination control
The separate or defined areas necessary to prevent contamination or mix-ups are deficient.
4Aseptic 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.
5Material and supplier control
There is a failure to thoroughly review the failure of a batch or any of its components to meet any of its specifications whether or not the batch has been already distributed.
6Aseptic processing and sterility assurance
Aseptic processing areas are deficient regarding the system for monitodng environmental conditions.
7Aseptic processing and sterility assurance
Procedures designed to prevent m icrobiological contamination ofdrug products purporting to be sterile are not established, written, and followed.
8Aseptic processing and sterility assurance
Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the room and equipment 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.
