# FDA 483 - AmericanBio Inc. - November 04, 2021

Source: https://www.keypedia.com/records/483/americanbio-inc/88bac0b8-3f36-47d4-a2ef-cd64dcfea4d9

> FDA 483 for AmericanBio Inc. on November 04, 2021. Product: other. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: AmericanBio Inc.
- Inspection Date: 2021-11-04
- Product Type: other
- Office Name: Division of Northeast Imports 
- Summary: 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.

## Related Officers

- [Sunita Pandey](https://www.keypedia.com/people/sunita-pandey/008e5bb8-0eb3-45d8-8524-734ac0454250)
- [Nabil Nakhoul](https://www.keypedia.com/people/nabil-nakhoul/d676e9c9-566c-4e59-84e8-1dc474e4e48d)

Company: https://www.keypedia.com/companies/americanbio-inc/2e0309bf-a145-4242-82f6-52fb80f4fece

Office: https://www.keypedia.com/offices/division-of-northeast-imports/b20599cf-9797-41fd-947f-6589ef596a94