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The FDA issued a five-observation Form 483 to Tropical Seas’ over-the-counter drug manufacturing facility in Holly Hill, Fla., for inadequate testing and equipment maintenance, among other lapses observed in a July 11-15 inspection — including several repeat observations from a 2019 warning letter. Read More
An over-the-counter homeopathic anti-snoring nasal spray manufactured by Green Pharmaceuticals contained “gross microbial contamination,” including large numbers of the aerobic bacteria Providencia rettgeri, as well as yeast and mold, the FDA said in a warning letter to the company. Read More
The FDA handed Granules Pharmaceuticals’ Chantilly, Va., drug manufacturing facility a six-observation Form 483 for deficient quality control procedures and other production lapses following a July 18 to July 22 inspection. Read More
The FDA issued a warning letter to active pharmaceutical ingredient (API) maker Nortec Quimica of Brazil for inadequate controls over computer systems and failure to review batch production and laboratory control records prior to API distribution to the U.S. Read More
Over-the-counter (OTC) drug manufacturer Midlab of Athens, Tenn., was slapped with a six-observation FDA Form 483 for failing to validate its drug manufacturing processes and equipment and its water system, in addition to using expired raw materials. Read More
To clear up any confusion about what the FDA considers delaying, denying, limiting, or refusing a drug or device inspection, the agency released a draft guidance on Thursday. Read More
An FDA inspection of Consolidated Chemical’s St. Louis, Mo., drug manufacturing facility from July 25 to Aug. 2 resulted in a Form 483 citing water leaks, lack of water testing, poor building condition and other lapses. Read More
The FDA issued a 10-observation Form 483 to Aurobindo’s Telangana, India, plant after a November visit, outlining several violations of current good manufacturing practices (cGMP). Read More
A large part of the FDA inspection process is reviewing documents and they need to be accessible promptly on request, an FDA inspections expert advised at the recent WCG FDAnews Annual FDA Inspections Summit in Washington, D.C. Read More
Complete document archives with self-explanatory file names are the top two — out of the top 10 — ways to be prepared for an FDA inspection, advised an FDA inspections expert at the WCG FDAnews Annual FDA Inspections Summit in Washington, D.C., Nov. 16-18. Read More