# FDA 483 - Charles River Laboratories, Inc. - February 11, 2020

Source: https://www.globalkeysolutions.net/records/483/charles-river-laboratories-inc/711c111b-a05d-4b0b-94f2-d0c76233324b

> FDA 483 for Charles River Laboratories, Inc. on February 11, 2020. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Charles River Laboratories, Inc.
- Inspection Date: 2020-02-11
- Product Type: drugs
- Office Name: Division of Northeast Imports 
- Summary: An FDA inspection of Charles River Laboratories, Inc. in Wilmington, MA, a contract testing laboratory, revealed significant deficiencies. Observations included inadequate environmental controls for temperature and humidity monitoring, a failure to thoroughly investigate unexplained discrepancies, and insufficient cleaning of equipment and utensils. These issues indicate a lack of proper controls over drug product manufacturing and quality processes.

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## Related Officers

- [Investigator](https://www.globalkeysolutions.net/people/erik-w-koester/2bbab081-6783-40a1-83c1-b219bde22bd1)

Company: https://www.globalkeysolutions.net/companies/charles-river-laboratories-inc/3a0d2bc1-66b3-441b-9c7f-1f32a705b2ef

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