483
AmericanBio Inc.AmericanBio Inc. – FDA 483, Nov 4, 2021
Record Details
AmericanBio Inc. in Canton, MA, underwent an FDA inspection from November 2-4, 2021. The inspection resulted in one observation, citing the firm for failing to maintain a device master record for its (b)(4) Reagent. This indicates a deficiency in the company's quality system requirements for device manufacturing.
View Company Profile
ID · 88bac0b8-3f36-47d4-a2ef-cd64dcfea4d9
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.