483
Wockhardt USA LLCFDA 483 - Wockhardt USA LLC - June 06, 2024
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An FDA inspection of Wockhardt USA LLC identified significant deficiencies in post-marketing surveillance and reporting. The firm lacked written procedures for monitoring adverse drug experiences and failed to submit numerous required periodic adverse drug experience reports and annual reports for its ANDA products. These issues indicate a systemic problem with regulatory compliance regarding drug safety and reporting obligations.
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ID · 646e029d-7dc3-46c4-8ff5-d58aad18c420