483
GLOBAL WIDGET LLCFDA 483 - GLOBAL WIDGET LLC - November 17, 2023
Record Details
GLOBAL WIDGET LLC, a drug manufacturer in Tampa, FL, was cited for significant deficiencies in its quality control and production systems during an FDA inspection. Observations included inadequate raw material and finished product testing, a non-compliant quality unit lacking written procedures and oversight, and a failure to establish proper production and process controls, including process validation and equipment qualification. These issues raise concerns about the identity, strength, purity, and quality of their OTC drug products.
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ID · b3ba67b2-13c3-4911-8f30-8e424c80b1f7