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Week of March 31st, 2019 | FDA Sent These Warning Letters to Pharma/Device Companies

Enforcement in terms of warning letter posting was busy this week. Among those issued were four that were sent to homeopathic drug product manufacturers, continuing a focus evident over the past two years. In addition, there were another two to drug product manufacturers and one to an in vitro diagnostics firm.

Week of March 25, 2019 | FDA Sent These Warning Letters to Pharma/Device Companies

We cover four warning letters from last week including two to pharmaceutical firms and two to compounding facilities. The FDA has not yet published the warning letter issued to Lupin Pharmaceuticals that the firm disclosed a couple weeks ago.

Week of March 10th, 2019 | FDA Sent These Warning Letters to Pharma/Device Companies

Warning letters posted this week include ones demonstrating FDA’s continued focus on over-the-counter (OTC) product manufacturers and manufacturers in India, including a particularly testy letter to Pfizer for a Hospira site in India that they are closing.

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