1Training and personnel
Clothing of personnel engaged in the manufacturing ofdrug products is not appropriate for the duties they perform.
Inspection Record
Downing Labs, LLC (formerly NuVision Pharmacy, Inc) — FDA 483 Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Other quality system
fhere are no wril1cn procedures for d 1 · d idcnt ity.
3Quality unit oversight
dcquote lab facilities for testing and approval or rejection of drug products are not available to the quality control unit.
4Aseptic processing and sterility assurance
Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the room to produce aseptic conditions.
5Material and supplier control
There is a failure to thoroughly n:view the failure ofa batch or any of its components to meet any ofits specifications whether or not the batch has been already distributed.
6Aseptic processing and sterility assurance
Aseptic processing areas are deficient regarding the system for monitoring environmental conditions.
7Aseptic processing and sterility assurance
Aseptic processing areas are deficient regarding systems for maintaining any equipment used to coolrol the aseptic conditions.
8Stability and storage
There IS no wriuen testing program designed to assess the stability characteristiC!.
9Aseptic processing and sterility assurance
Each batch ofdrug product purporting to be sterile and pyrogen-free is not laboratory tested to determine conformance to such requirements.
10Laboratory and QC controls
Testing and release ofdrug producr for distribution do not include appropriate laboratory detennination ofsatisfactory conformance to the identity and strength ofeach active ingredient prior to release.
11Aseptic processing and sterility assurance
Procedures designed to pr~vent microbiological contamination ofdrug products purporting to be sterile are not established.
12Equipment and facility
Equipment and utensils are not maintained at appropriate intervaJs to prevent malfunctions and contamination that would alter the safety, identity, strength, quaJity or purity of the drug product S~c.ifically, your firm has never conducted preventive maintenance oo or lyophilizer used for the processing of•_nJectable ~rug p~oducts.
13Other quality system
Mruiter producnon and comrol records lack complete manufacturing and conrrol instructions.
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.
