483
E-Beam Services, Inc.FDA 483 - E-Beam Services, Inc. - April 27, 2023
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
E-Beam Services, Inc., a medical device sterilizer in Cranbury, NJ, received two observations during an FDA inspection. The findings highlight deficiencies in the firm's record-keeping practices, specifically regarding the lack of detailed descriptions for document changes and incomplete device history records that omit critical processing times for sterilization.
Open in Dashboard
ID · 4fd67091-cdc3-4150-9a48-e1c91d6acb2c