1Aseptic processing and sterility assurance
Aseptic processing areas are deficient regarding the system for monitoring environmental conditions.
Inspection Record
RX South LLC DBA RX3 Pharmacy — FDA 483 Findings
Inspectors Brooke K. HigginsThe inspectors who signed the published document.Inspector lookup
View the regulator's official source The source document is always the basis for judgement.
Findings
2Quality unit oversight
The quality control unit lacks responsibility for approving or rejecting drug products manufactured and processed under contract by another company.
3Aseptic processing and sterility assurance
Procedures designed to prevent microbiological contamination ofdrug products purporting to be sterile are not established, written, and followed.
4Laboratory and QC controls
Testing and release ofdrug product for distribution do not include appropriate laboratory deteonin.ation ofsatisfactory conformance to the .final specifications prior to release.
5Aseptic processing and sterility assurance
Procedures designed to prevent microbiological contamination ofdrug products purporting to be sterile do not include adequate validation ofthe sterilization process.
6Other quality system
Containers and closures are not tested for conformance with all appropriate written procedures .
7Equipment and facility
Routine inspection of equipment is oot performed according to a written program designed to assure proper performance.
8Process 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.
9Training and personnel
Clothing ofpersonnel engaged in the manufacturing and processing ofdrug products is not appropriate for the duties they perfonn.
10Aseptic processing and sterility assurance
Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the room and equipment to produce aseptic conditions.
11Aseptic processing and sterility assurance
Aseptic processing areas are deficientregarding air supply tbat is filtered throughhigh-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.
