1Aseptic processing and sterility assurance
Aseptic processing areas are deficient regarding the system for monitoring environmental conditions.
Inspection Record
Wellness Pharmacy, Inc — FDA 483 Findings
Inspectors Samantha J. Bradley · Patrick C. DooleyThe inspectors who signed the published document.Inspector lookup
View the regulator's official source The source document is always the basis for judgement.
Findings
2Equipment and facility
Equipment and utensils are not sanitized at appropriate intervals to prevent contamination that would alter the safely, identity, strength, quality or purity of the drug product.
3Stability and storage
There is no written testing program designed to assess the stability characteristics ofdrug products.
4Equipment and facility
Routine calibration ofmechanical and electronic equipment is not performed according to a written program designed to assure proper performance.
5Aseptic processing and sterility assurance
Procedures designed to prevent microbiological contamination ofdrug products purporting to be sterile are not established, written, and followed.
6Equipment and facility
Buildings used in the manufacture, processing, packing, or holding ofa drug prodnct do not have the suitable construction to filcilitate cleaning, maintenance, and proper operations.
7Laboratory and QC controls
Testing and release of drug product for distribution do not include appropriate laboratory determination of satisfactory conformance to the identity and strength ofeach active ingredient prior to release.
8Contamination control
Protective apparel is not worn as necessary to protect drug products from contamination.
9Aseptic processing and sterility assurance
Each batch ofdrug product purporting to be pyrogen-free is not laboratory tested to determine conformance to such requirements.
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.
