483
Avery Biomedical Devices, Inc.FDA 483 - Avery Biomedical Devices, Inc. - April 17, 2017
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
During an inspection from April 13-17, 2017, the FDA observed one significant issue at Avery Biomedical Devices, Inc. in Commack, NY. The firm, a medical device manufacturer, failed to adequately establish procedures for controlling environmental conditions in its clean room. This indicates a lack of proper monitoring for temperature and humidity, which is critical for product quality and safety.
Open in Dashboard
ID · 2d5194de-4889-48d0-ab21-7fa0fd9500da