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483
•Access Business Group LLC•June 24, 2022

Access Business Group LLC – FDA 483, Jun 24, 2022

Record Details

Access Business Group LLC in Ada, MI, a drug manufacturer, was inspected by the FDA from June 15-24, 2022, resulting in two observations. The inspection revealed deficiencies in batch production records, which lacked complete information for critical steps, and issues with equipment storage, where portable vessels were exposed to a dusty atmosphere, posing a risk of cross-contamination.

Company
Access Business Group LLC
Inspection date
June 24, 2022
Product type
drugs
Office
Division of Pharmaceutical Quality Operations III
People
  • Constantin Y. Philopoulos
  • Amanda M. Dunneback (investigator)
View Company Profile

ID · 0f60ce53-3cbc-4752-a69e-07bd352ec940

Other documents for Access Business Group LLC
  • 483 - 2026-06-05June 5, 2026

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