1Material and supplier control
There is a failure to thoroughly review the failure of a batch or any of its components to meet any of its specificatio ns whether or not the batch has been already distributed.
Inspection Record
NuVision Pharmacy, Inc. — FDA 483 Findings
Inspectors Stephen D. BrownThe inspectors who signed the published document.Inspector lookup
View the regulator's official source The source document is always the basis for judgement.
Findings
2Stability and storage
There is no written testing program designed to assess the stability characteristics ofdrug products.
3Process validation
There are no written procedures fur 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.
4Process validation
The in process control procedures were deficient in that they did not include an examination ofthe adequacy of mixing to assure uniformity and homogeneity.
5Laboratory and QC controls
Testing and release of drug product for distribution do not include appropriate laboratory determination of satisfactor y conformance to the prior to release .
6Aseptic processing and sterility assurance
Procedures designed to prevent microbiological contamination ofdrug products pwporting to be sterile are not established.
7Training and personnel
Clothing of personnel engaged in the processing of drug products is not appropriate for the duties they perform.
8Documentation and records
Master production and control records lack complete manufactming and control instructions.
9Aseptic processing and sterility assurance
Aseptic processing areas are deficient regarding systems for maintaining any equipment used to control the aseptic conditions.
10Aseptic processing and sterility assurance
Aseptic processing areas are deficient regarding the system for monitoring environmental conditions.
11Laboratory and QC controls
Each batch of drug product required to be free of objectionable 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.
