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The FDA sent a warning letter to Ranier’s Compounding Laboratory, based in Jeannette, Pa., noting serious deficiencies in sterile procedures and GMPs. Read More
An FDA investigation into serious quality problems at a Florida pharmaceutical company revealed a litany of unsound practices in the manufacture of experimental drugs. Read More
The FDA hit multiple manufacturers with extensive Form 483s, including an Ohio outsourcing facility where failures to adhere to GMP and overall sterility, cleaning and quality control issues proved to be problems repeated from an inspection a year before. Read More
What’s the best way to get ready for an FDA GMP inspection? Practice, says international quality expert Thomas Peither. Self-inspection or a fresh set of eyes in the form of an external consultant play an important role in audit preparation. Read More
FDA inspectors found extensive cleanliness and sterility issues during visits to California Pharmacy and Compounding Center in Newport Beach, Calif., in March and April. Read More
The FDA issued a warning to an Oklahoma drug manufacturer after inspectors found significant GMP violations, including a lack of product testing. Read More