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Norwich Pharmaceuticals was hit with an FDA Form 483 for several quality deficiencies observed during a March 8 to 16 inspection of its Jamaica, N.Y., facility. Read More
Over-the-counter drugmaker Sanit Technologies, which does business as Durisan, drew the FDA’s attention for water quality and other deficiencies observed during a March 1-5 inspection of its plant in Sarasota, Florida. Read More
The FDA issued a warning letter to generic drugmaker Lupin for good manufacturing practice (GMP) violations observed during an inspection of its plant in Somerset, New Jersey. Read More
Norwich Pharmaceuticals was hit with an FDA Form 483 for several quality deficiencies observed during a March 8 to 16 inspection of its Jamaica, N.Y., facility. Read More
An FDA inspection of Dr. Reddy’s active pharmaceutical ingredient (API) manufacturing plant in Middleburgh, New York earlier this year found lapses in good manufacturing practice (GMP). Read More
The FDA said that it plans to gradually resume its on-site drugmaker inspections beginning in July with the intent to be back to normal operations by September. Read More
In the worst-case scenario, where new variants emerge and/or new pandemic-related challenges occur, the agency said it would continue to rely more heavily on alternative oversight tools. Read More
The FDA said yesterday that it plans to gradually resume its on-site drugmaker inspections beginning in July with the intent to be back to normal operations by September. Read More
A worker at Eli Lilly’s Branchburg, N.J., facility filed an anonymous complaint last month, alleging improper conduct at the manufacturing site, a location that’s previously been the subject of FDA scrutiny. The company’s response is that its COVID-19 neutralizing antibody commitments are still on track. Read More