483
Flamma USA LLCFlamma USA LLC – FDA 483, Jun 20, 2025
Record Details
An FDA inspection of Flamma USA LLC, an API manufacturer in Malvern, PA, revealed significant deficiencies in quality control and manufacturing processes. Observations included a lack of written procedures for equipment cleanliness, inadequate laboratory testing facilities, and failure to implement formal change control for production changes. These issues indicate a need for improved adherence to good manufacturing practices.
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ID · 975bec0e-a438-4620-b66f-16ac00d402bd
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