We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
The FDA cited Reliance Life Sciences for a long list of deficiencies observed during an inspection of the API manufacturer’s facility in Navi Mumbai in December. Read More
The FDA hit Surmasis Pharmaceutical of Des Moines, Iowa with a Form 483 after a February inspection revealed problems with laboratory records, computer systems and equipment inspections. Read More
The FDA issued warnings to the following facilities in Australia, Korea, the European Union and the United States for deficiencies in records, documentation, GMPs, testing and validation: Read More
The FDA invited drugmakers to allow non-regulatory site visits of their facilities by CDER and CBER staff as part of its Quality Metrics Program. Read More
CDER launched two new efforts to gather feedback about the use of quality metrics in modernizing drug quality systems, calling for participants in a voluntary pilot program and encouraging meeting requests. Read More
The FDA released a list of alternative suggestions for complying with CGMP requirements for drug combination products that covers stability testing, release for distribution, reserve samples and special testing requirements. Read More
The FDA observed multiple deficiencies related to equipment and quality control during a November inspection of Douglas Manufacturing’s finished drug facility in Lincoln, Auckland. Read More
The FDA issued a Form 483 to Noven Pharmaceuticals after observing numerous problems at the transdermal drug manufacturer’s Miami, Florida facility. Read More
The Trump administration is urging the Supreme Court to take up a case testing whether the FDA’s refusal to approve a warning label on drugs preempts state laws that may require such labels. Read More
The FDA hit Pennsylvania drugmaker Bio-Pharm with a Form 483 after an agency inspection in January revealed poor equipment maintenance and quality control issues. Read More