# FDA 483 - Charles River Laboratories, Inc. DBA Charles River, Endosafe - January 13, 2016

Source: https://www.keypedia.com/records/483/charles-river-laboratories-inc-dba-charles-river-endosafe/282aa946-877e-48c9-bc97-c1437a2a8a99

> FDA 483 for Charles River Laboratories, Inc. DBA Charles River, Endosafe on January 13, 2016. 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
- Inspection Date: 2016-01-13
- Product Type: biologics
- Office Name: Office of Biological Products Operations - Division I
- Summary: Charles River Laboratories, Inc. dba Charles River Endosafe in Charleston, SC, a licensed LAL Test Vial and Cartridge Manufacturer, was cited for significant deficiencies during an FDA inspection. The observations primarily concern inadequate aseptic processing controls, including media fills, environmental monitoring, cleaning procedures for the Class 100 fill room and equipment, and validation of critical processes like smoke studies and expiration dating. These issues indicate a lack of control over manufacturing processes that could impact product quality and sterility.

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

Office: https://www.keypedia.com/offices/office-of-biological-products-operations-division-i/49c53dac-7724-4c8c-8708-4f5779ea69c1