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483
•LGM Pharma, LLC•April 14, 2022

LGM Pharma, LLC – FDA 483, Apr 14, 2022

Record Details

LGM Pharma, LLC in Boca Raton, FL, was issued a Form 483 with two observations following an FDA inspection. The firm's quality system was found deficient, specifically regarding its vendor qualification procedures and the investigation of deviations. These issues indicate a lack of adequate control over the quality and status of active pharmaceutical ingredients (APIs) and their suppliers.

Company
LGM Pharma, LLC
Inspection date
April 14, 2022
Product type
drugs
Office
Office of Medical Device and Radiological Health Operations Central
People
  • Kayla V. Sprague (Pharmaceutical Investigator)
  • Joanne E. King (Special Assistant)
View Company Profile

ID · c757d8b7-0b68-4155-8d4a-1d3796e23694

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