AmericanBio Inc.November 4, 2021

FDA 483 - AmericanBio Inc. - November 04, 2021

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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.

Company: AmericanBio Inc.
Inspection Date: November 4, 2021
Product Type: Other
Office: Division of Northeast Imports
People: Sunita Pandey
Nabil Nakhoul

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ID · 88bac0b8-3f36-47d4-a2ef-cd64dcfea4d9