483
Phelan Mfg CorpFDA 483 - Phelan Mfg Corp - April 18, 2019
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
Phelan Mfg Corp, a medical device manufacturer in Minneapolis, was inspected by the FDA, resulting in one observation. The firm was cited for not establishing procedures for receiving, reviewing, and evaluating complaints by a formally designated unit. This indicates a deficiency in their quality system regarding complaint handling documentation and processes.
Open in Dashboard
ID · 8e72dd7e-392b-4286-8ca6-ee5451c41c0e