Owen Biosciences, an over-the-counter drug manufacturer in Baton Rouge, La., drew a Form 483 inspection report from the FDA detailing observations about good manufacturing practices at the company’s facility. Source:…
An FDA inspection of Romark Global Pharma’s Manati, Puerto Rico drug manufacturing facility revealed problems with contamination of drug products and equipment. Source: Drug GMP Report
UCSF Radiopharmaceutical Facility drew a lengthy inspection report from the FDA for failing to fully investigate out-of-specification results and other quality lapses. Source: Drug GMP Report
Pro Breath MD and Vibrant Health Care: The FDA has issued a flood of warning letters during the pandemic to crack down on marketers of sham COVID-19 treatments. Source: Drug…
The FDA published final guidance designed to help drug compounders recognize, prevent and respond to insanitary conditions at their facilities. Source: Drug GMP Report
The FDA’s Office of Regulatory Affairs (ORA) has determined that general and prioritized inspections will remain preannounced for the foreseeable future in order to ensure the safety of those involved…
Many of the guidance documents for drug developers and manufacturers that the FDA has issued during the COVID-19 pandemic are likely to continue to be in effect long after the…
FDA investigators cited five drug facilities for failures ranging from late field reports to lax control of data, complaint handling and training. Source: Drug GMP Report
The FDA has developed two new documents that it wants drug sponsors to use for annual postmarket reporting and is requesting comments on them in a new draft guidance. Source:…
The FDA issued warning letters to three drug manufacturing facilities for failures in their current good manufacturing practices, including lax environmental monitoring and inadequate process validations. Source: Drug GMP Report