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There is a strong correlation between a surge in warning letters over data integrity issues and increased FDA inspections of manufacturers in India and China — one that could cause production headaches for U.S. drugmakers partnering with these facilities. Read More
Shortly after receiving an FDA warning letter for major quality deficiencies, Indian drugmaker was slammed for data integrity issues and GMP violations by the World Health Organization. Read More
The FDA has slapped hair and skincare products maker Alikay Naturals with a warning letter that takes the company to task for the presence of lead in one of its products. Read More
Three stem cell treatment centers have been hit with an FDA warning letter critical of their recordkeeping and lack of required licenses for their clinical procedures. Read More
Heparin is back in the news, after France’s National Agency for Medicines and Health Products Safety issued a GMP noncompliance statement to China’s Dongying Tiandong Pharmaceutical, which manufactures the active ingredients of Lovenox and heparin. Read More
The FDA has slammed yet another Indian drugmaker for data integrity issues. This time it rebuked Ipca Laboratories for data falsification at three of the company’s manufacturing facilities. Read More
Dietary supplement maker TJM Resale’s Synaptik Supplements & Ligand Solutions was slapped with an FDA warning letter over the sale of unapproved and misbranded drugs. Read More