483
Granules Pharmaceuticals Inc.Granules Pharmaceuticals Inc. – FDA 483, Apr 3, 2026
Record Details
An FDA inspection of Granules Pharmaceuticals Inc. in Chantilly, VA, revealed significant deficiencies in quality control and facility maintenance. The firm failed to adequately investigate recurring stability failures and uncharacterized impurities, and did not consistently adhere to its written stability testing program. Additionally, issues were noted with incomplete batch production records and critical HVAC equipment failures leading to product contamination.
View Company Profile
ID · d8b4fccb-5ec0-4d32-b070-267fbae547e0
Other documents for Granules Pharmaceuticals Inc.
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.