483
Pharmaloop, S.L.FDA 483 - Pharmaloop, S.L. - April 16, 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
Pharmaloop, S.L. in Alcala de Henares, Spain, was inspected by the FDA from April 8-16, 2024, and received a Form 483 with two observations. The inspection revealed significant issues with preventing microbiological contamination in sterile drug products, including problems with environmental monitoring and aseptic filling processes. Additionally, the firm failed to adequately test raw materials used in drug product manufacturing.
Open in Dashboard
ID · c65886c6-337e-4fc0-8f55-a3bc8a551b25