1Equipment and facility
Equipment qualification is not performed according to a written program designed to assure proper performance.
Inspection Record
RxSouth, LLC (dba RX3 Pharmacy) — FDA 483 Findings
Inspectors Rachel C. HarringtonThe inspectors who signed the published document.Inspector lookup
View the regulator's official source The source document is always the basis for judgement.
Findings
2Other quality system
Containers and closures are not tested for conformance with all appropriate written procedures.
3Aseptic processing and sterility assurance
Aseptic manufacturing practices are inadequate.
4Material and supplier control
Each component is not tested for conformity with all appropriate written specifications for purity, strength, and quality.
5Laboratory and QC controls
Established test procedures are not followed.
6Laboratory and QC controls
Each batch of drug product required to be free of objectionable microorganisms is not tested through appropriate laboratory testing.
7Process validation
There are no written procedures for production and process controls designed to assure that the drug products have the identity, strength, quality, and purity they purport or are represented to possess.
8Environmental monitoring
The environmental monitoring program is inadequate.
9Aseptic processing and sterility assurance
Procedures designed to prevent microbiological contamination ofdrug products purporting to be sterile do not include adequate validation ofthe aseptic process.
10Laboratory 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 of each active ingredient prior to release.
11Stability and storage
There is no written testing program designed to assess the stability characteristics of drug products.
12Documentation and records
Batch production and control records are not kept for each batch of drug product produced and do not include complete information relating to the production and control of each batch.
13Deviation, CAPA, and investigation
There is a failure to thoroughly review any unexplained discrepancy whether or not the batch has been already distributed.
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.
