483
TJA Health LLCFDA 483 - TJA Health LLC - January 29, 2024
Record Details
TJA Health, LLC, an OTC drug manufacturer in Joliet, IL, was cited for significant deficiencies during an FDA inspection. The observations primarily concern a lack of adequate written procedures, process validation, raw material testing, and quality control investigations. The firm also failed to conduct annual product reviews, establish hold time studies, and perform stability testing for its drug products.
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ID · 64252f43-a445-4090-8d75-34c08f7c8494