# FDA 483 - Acme Monaco Corporation - April 17, 2019

Source: https://www.keypedia.com/records/483/acme-monaco-corporation/97850888-13d0-4936-91a4-32e9d67b449b

> FDA 483 for Acme Monaco Corporation on April 17, 2019. Product: device. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Acme Monaco Corporation
- Inspection Date: 2019-04-17
- Product Type: device
- Office Name: Division of Northeast Imports 
- Summary: An FDA inspection of Acme Monaco Corporation, a medical device manufacturer in New Britain, CT, revealed significant deficiencies in their quality system. Observations included device history records not demonstrating manufacturing in accordance with device master records, specifically regarding product specifications and coating verification. Additionally, the firm failed to adequately establish and log schedules for equipment cleaning and maintenance.

## Related Documents

- [WARNING_LETTER - 2014-03-07](https://www.keypedia.com/records/warning_letter/acme-monaco-corporation/11990743-d584-412d-9220-5e7549bd3f71)

## Related Officers

- [Power Trader/Data Scientist](https://www.keypedia.com/people/jeffrey-j-thibodeau/62b74030-4aef-400b-8ae2-8bf84712d813)
- [Preston M. Lee](https://www.keypedia.com/people/preston-m-lee/e44adac3-a915-4bfb-8b06-a41ea5803358)

Company: https://www.keypedia.com/companies/acme-monaco-corporation/703a1e2b-88fb-4175-8191-76f39b69bdc3

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