# FDA 483 - Emergent Biodefense Operations Lansing LLC - April 12, 2016

Source: https://www.keypedia.com/records/483/emergent-biodefense-operations-lansing-llc/5507cc83-bd28-405f-bd89-2a8b07648040

> FDA 483 for Emergent Biodefense Operations Lansing LLC on April 12, 2016. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Emergent Biodefense Operations Lansing LLC
- Inspection Date: 2016-04-12
- Product Type: biologics
- Office Name: Office of Biological Products Operations - Division I
- Summary: An FDA inspection of Emergent BioDefense Operations Lansing LLC, a licensed biological manufacturer in Lansing, Michigan, revealed several deficiencies in their manufacturing and quality control processes for Anthrax Vaccine Adsorbed. Observations included inadequate investigations into mold contamination and out-of-specification potency results, lack of established reject limits and reinspection criteria for visual inspection, and insufficient environmental monitoring. The findings indicate a need for improved controls and adherence to established procedures to ensure product quality and safety.

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Company: https://www.keypedia.com/companies/emergent-biodefense-operations-lansing-llc/7a502584-4071-4f7a-bb11-7272db98f478

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