1Aseptic processing and sterility assurance
Procedures designed to prevent microbiological contamination ofdrug products purporting to be sterile are not established, written, and followed.
Inspection Record
Wells Pharmacy Network LLC — FDA 483 Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Other quality system
on the FDA 483 dated 07/26/2013.
3Other quality system
on the fda 483 dated 03/07/2014 and
4Other quality system
on the FDA 483 dated 03/07/2014.
5Quality unit oversight
The quality control unit lacks the responsibility and authority to approve and reject all drug products.
6Aseptic processing and sterility assurance
Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the room and equipment to produce aseptic conditions.
7Other quality system
on the FDA 483 dated 07/26/ 13.
8Laboratory and QC controls
Each batch ofdrug product required to be free ofobjectionable microorganisms is not tested through appropriate laboratory testing.
9Stability and storage
The written stability program does not include testing of drug products for reconstitution after they are reconstituted.
10Other quality system
on the FDA 483 dated 07/2612013.
11Complaint and recall handling
Procedures describing the handling ofwritten and oral complaints related to drug products are not written or followed.
12Training and personnel
Clothing of personnel engaged in the processing ofdrug products is not appropriate for the duties they perform.
13Aseptic processing and sterility assurance
Aseptic processing areas are deficient regarding the system for monitoring environmental conditions.
14Documentation and records
Batch production and control records do not include complete information relating to the production and control ofeach batch.
15Stability and storage
There is no written testing program designed to assess the stability characteristics of drug products.
16Other quality system
on the FDA 483 dated 03 /07/2014 and
17Other quality system
on the FDA 483 dated 03/ 07/2014 and
18Aseptic processing and sterility assurance
Aseptic processing areas are deficient regarding air supply that is filtered through high-efficiency particulate air filters under positive pressure.
19Material and supplier control
Establishment ofthe reliability ofthe component supplier's report of analyses is defi~ient in that the test results are not appropriately validated at appropriate intervals.
20Other quality system
on the FDA 483 dated 07/26120 13.
21Process 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.
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.
