FDA 483 - National Vitamin Company Inc - December 03, 2025
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An FDA inspection of National Vitamin Company Inc in Casa Grande, AZ, a drug product manufacturer, revealed two significant quality control deficiencies. The firm failed to adequately test finished drug products for objectionable microorganisms like Burkholderia cepacia and did not perform required identity testing on every container of inactive ingredients such as glycerin and propylene glycol before use in manufacturing. These issues indicate a lack of assurance regarding product safety and quality.
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ID · 8b91fef1-eaa7-498a-ad10-d92c2d32f68f