# FDA 483 - Charles River Laboratories, Inc. DBA Charles River, Endosafe - Unknown Date

Source: https://www.globalkeysolutions.net/records/483/charles-river-laboratories-inc-dba-charles-river-endosafe/708d8124-17d4-49df-a8be-e32d99ce84bc

> FDA 483 for Charles River Laboratories, Inc. DBA Charles River, Endosafe on Unknown Date. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Charles River Laboratories, Inc. DBA Charles River, Endosafe
- Product Type: biologics
- Office Name: Atlanta District Office
- Summary: Charles River Laboratories, Inc., dba Charles River Endosafe in Charleston, SC, a licensed LAL Test Vial and Cartridge Manufacturer, was cited for significant quality system deficiencies during an FDA inspection. Observations included incomplete investigations, manufacturing line failures leading to high rejection rates, and deficient corrective actions. The firm also failed to properly evaluate material changes and process validations, and did not notify the FDA about new product distribution.

## Related Documents

- [483 - 2016-01-13](https://www.globalkeysolutions.net/records/483/charles-river-laboratories-inc-dba-charles-river-endosafe/282aa946-877e-48c9-bc97-c1437a2a8a99)
- [483 - 2025-09-09](https://www.globalkeysolutions.net/records/483/charles-river-laboratories-inc-dba-charles-river-endosafe/88dd81a9-c34f-45a5-9e44-36395e21d329)

## Related Officers

- [James L. Kenney](https://www.globalkeysolutions.net/people/james-l-kenney/7fb5d88f-83a4-4a01-878d-9e3f230f78eb)
- [Strategic Expert at NovoNordisk; Retired from FDA](https://www.globalkeysolutions.net/people/debra-m-emerson/58bd7fac-28eb-4369-b149-13a24cc00cf7)

Company: https://www.globalkeysolutions.net/companies/charles-river-laboratories-inc-dba-charles-river-endosafe/a4d1dc9b-cc00-4585-ad5e-22952dbb2df4

Office: https://www.globalkeysolutions.net/offices/atlanta-district-office/7586d99a-288e-49d1-8c3d-d88b7354b7a7