1Other quality system
on the FDA 483 dated 07!16/13.
Inspection Record
Wells Pharmacy Network LLC — FDA 483 Findings
Inspectors Nicole E. Knowlton · Gene R. GunnThe inspectors who signed the published document.Inspector lookup
View the regulator's official source The source document is always the basis for judgement.
Findings
2Deviation, CAPA, and investigation
Investigations of did not extend t.o other batches ofthe same drug product.
3Aseptic processing and sterility assurance
Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the room and equipment to produce aseptic conditions.
4Training and personnel
Clothing ofpersonnel engaged in the processing ofdrug products is not appropriate for the dutie.o; they perfom1.
5Other quality system
on the FDA 483 dated 07/26/t3.
6Aseptic processing and sterility assurance
Aseptic processing areas are deficient regarding the system for monitoring environmental conditions.
7Other quality system
on the FDA 483 dated 07/26/13.
8Equipment and facility
Procedures describing the calibration ofinstruments, apparatus, gauges and recording devices are not written or followed.
9Aseptic processing and sterility assurance
Procedures designed to prevent microbiological contamination ofdrug products purporting to be sterile are not established, written, and followed.
10Equipment and facility
Routine calibration of equipment is not performed according to a written program des igned to assure proper performance.
11Complaint and recall handling
Procedures describing the handling of written and oral complaints related to drug products are not written or followed.
12Stability and storage
There is no written testing program designed to assess the stability characteristics ofdrug products.
13Laboratory and QC controls
Each batch ofdrug product required to be free ofobjectionable microorganisms is not tested through appropriate laboratory testing.
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.
