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The FDA has issued a warning letter to About Mineral, an Orange, Ca-based company that sells Puriton, a direct-to-consumer line of topical skin products which it claims have been tested and are effective against COVID-19. Read More
The FDA sent a warning letter to Dibar Nutricional, an over-the-counter drug manufacturer in Morelia, Mexico, after a records-based inspection revealed significant lapses at the facility. Read More
The U.S. Special Counsel has released details of a former FDA inspector’s allegations against the agency, including that it may have dropped the ball in an inspection of a Merck plant and possibly downgraded certain inspection findings without filing required documentation, claims he described as “troubling” in a letter to the White House. Read More
The FDA has issued a warning letter to Tarmac Products, an over-the-counter (OTC) drugmaker in Miami Gardens, Florida, writing up the firm for incomplete testing and stability data, insufficient assay failure investigations and other violations. Read More
The FDA sent a warning letter to Dibar Nutricional, an over-the-counter drug manufacturer in Morelia, Mexico, after a records-based inspection revealed significant lapses at the facility. Read More
The FDA has issued a warning letter to HealthQuilt, the sponsor of a clinical trial evaluating a drug product as a COVID-19 treatment, citing its failure to submit an Investigational New Drug (IND) application for the product being studied, among other problems. Read More
The European Medicines Agency (EMA) is reportedly conducting an audit that could conclude this month of the Serum Institute of India (SII), the largest vaccine manufacturer in the world, as the EU faces delays to AstraZeneca (AZ)/Oxford’s COVID-19 vaccine shipments. Read More
Allay Pharmaceuticals, a contract drug manufacturer in Hialeah, Florida, drew a warning letter from the FDA arising from a May 5-15, 2020 inspection in which investigators found serious quality lapses, including a lack of validation for manufacturing processes and other problems. Read More
Allay Pharmaceuticals, a contract drug manufacturer in Hialeah, Florida, drew a warning letter from the FDA arising from a May 5-15, 2020 inspection in which investigators found serious quality lapses, including a lack of validation for manufacturing processes and other problems. Read More
A Lupin Pharmaceuticals facility in Somerset, N.J., has received a 38-page Form 483 with more than a dozen observations following a Sept. 10-Nov. 5, 2020, inspection by the FDA. The FDA’s options at this point are to do another inspection or to take regulatory action, such as a warning letter to the company. Read More