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Submissions of manufacturing establishment information (MEI) by manufacturers are about to be changed. A new FDA draft guidance has been published outlining the requirements and implementation regarding valid electronic submission of MEIs. Read More
The FDA finalized guidance in December on suspect products and notification, describing when to file a report, and added example scenarios of fraudulent activity that would warrant alerting the agency, trading partners and wholesale distributors. Read More
The FDA issued warning letters to two international drug manufacturers for breaching GMP standards by failing to develop procedures to maintain the appropriate quality controls. Read More
An FDA inspection of Isometric Pharmacy’s Salt Lake City facility revealed several GMP violations that rendered its drugs adulterated and resulted in a warning letter. Read More
The FDA issued Spanish API maker Interquim a warning letter for failing to establish adequate cleaning procedures and maintain quality records data in violation of GMP standards. Read More
The FDA refused to approve Cempra’s community-acquired bacterial pneumonia antibiotic Solithera, citing manufacturing and safety concerns in a complete response letter. Read More
FDA’s San Juan district office has found numerous problems at a Baxter sterile drug manufacturing facility in Jayuya, Puerto Rico following a series of inspections in late August through early October. Read More
During the coming transfer of political power, the FDA will survive major changes despite strong rhetoric and vague promises for reform, said a long-time FDA insider. Read More
Nearly a year after Sun Pharma began implementing a remediation plan to resolve GMP deficiencies at its Halol, India facility, the FDA continues to fault the company for failing to establish and maintain quality controls in a nine-observation Form 483. Read More