483
Flamma USA LLCFDA 483 - Flamma USA LLC - June 20, 2025
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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