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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
Representatives of generic drugmakers put forward several ideas for the FDA to consider for manufacturing facility inspections during a January meeting to discuss the agency’s commitments as part of the reauthorization of the Generic Drug User Fee Act (GDUFA). Read More
The FDA is using a temporary process during the pandemic for communicating issues it finds after reviewing records or other information requested in lieu of or in advance of pre-approval or pre-license inspections for Center for Drug Evaluation and Research (CDER)-regulated products. Read More
Eywa Pharma’s generic drug manufacturing facility in Cranbury, N.J., drew a Form 483 from the FDA for quality deficiencies observed during an agency inspection. Read More
The FDA called on drug compounders to know their active pharmaceutical ingredient (API) suppliers as it issued a warning letter to Houston, Texas-based Professional Compounding Centers of America (PCCA) for using a supplier whose drug ingredients had been placed on an import alert. Read More