483
Water-Jel Technologies, LLCFDA 483 - Water-Jel Technologies, LLC - September 20, 2024
Discuss this record with AI
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.
Record Details
Water-Jel Technologies, LLC in Huntersville, NC, was inspected and received a Form 483 with two observations. The firm failed to thoroughly review unexplained discrepancies and complete stability OOS and non-conformance investigations in a timely manner. Additionally, the written stability testing program was not followed, specifically regarding the establishment of drug product stability protocols.
- Office
- Atlanta District Office
- Person
Open in Dashboard
ID · 7b34f25e-555e-47ad-9444-ecd5b2a559da