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,…

The FDA issued a warning letter to STI Pharma for serious violations of adverse event reporting requirements. Source: Drug GMP Report

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…

Four foreign API makers have landed FDA warning letters accusing them of violations ranging from data falsification to finished product deficiencies. Source: Drug GMP Report

The FDA has slapped Polydrug Laboratories’ Mumbai facility with a warning letter for alleged GMP deviations seven months after it received a ban on U.S. imports. Source: Drug GMP Report

The FDA has handed Infusion Options a warning letter for a slew of GMP deficiencies in compounding sterile products and failing to meet 503B conditions for outsourced compounding operations. Source:…

The FDA has issued Form 483s to four drugmakers in the past month over a variety of GMP lapses at their facilities. Source: Drug GMP Report

Four compounders recently received FDA warning letters that faulted them over sterility concerns and other issues. Source: Drug GMP Report

Xellia Pharmaceuticals and the FDA have agreed on a modified consent decree so Xellia can resume manufacturing at the Bedford, Ohio, site it purchased from Ben Venue Laboratories. Source: Drug…

The FDA has zeroed in on five dietary supplement makers in recent weeks, complaining of a laundry list of issues that range from promotional claims to GMP problems. Source: Drug…