FDA 483 - Premium Production, LLC - May 27, 2022
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Premium Production, LLC received an FDA Form 483 citing numerous significant deficiencies in its manufacturing and quality control operations for dietary supplements. The firm lacked essential written procedures for quality control, product specifications, master manufacturing records, and complaint handling, with many issues being repeat observations. These failures indicate a systemic lack of control over product identity, purity, strength, and composition, posing a risk of adulterated products reaching consumers.
- Office
- Denver District Office
- Person
ID · 66052a0f-b088-40c8-b929-22e2eab39b45