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Pharma Blog2019-02-08T15:50:42-05:00

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404, 2019

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

April 4th, 2019|Categories: Biopharma / Pharma, CGMP, Clinical, FDA, FDA Warning Letters, FDAzilla, quality assurance|

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.

1903, 2019

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

March 19th, 2019|Categories: Biopharma / Pharma, CGMP, Clinical, FDA, FDA Warning Letters, FDAzilla, quality assurance|

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.