483
Alvogen, IncAlvogen, Inc – FDA 483, Jun 10, 2021
Record Details
Alvogen, Inc. in Morristown, NJ, underwent an inspection of its corporate office, revealing a significant deficiency in its Risk Evaluation and Mitigation Strategy (REMS) program. The firm failed to maintain a required REMS Program website link on its product website, which is a critical component of its approved REMS Implementation System. This indicates a lapse in adhering to established safety and communication protocols for opioid analgesic products.
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ID · 4c5dff3f-5a91-4cfa-9d81-935cfaa13575
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