Japan to Share GMP Inspection Findings on API Makers with EU, FDA, TGA
Japan’s Pharmaceutical and Medical Devices Agency is joining the ranks of the FDA, the EMA and a few other drug regulators by agreeing to participate in a program that allows…
FDA 483 Finds Deficiencies at Baxter Healthcare Facility
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…
Spanish Regulator Suspends Authorization of Drugmaker
Spain’s Agency of Medicines and Medical Devices has ordered Madrid vaccine maker Angulema to suspend manufacturing and recall batches of its drug products due to significant GMP deficiencies. Source: Drug…
FDA Letters Target Foreign API Makers Over Data Falsification and Deficiencies
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
Polydrug Lands FDA Warning Letter on Post-ban Data Integrity Claims
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
FDA Letter Blasts Infusion Options Over Sterility Concerns at Facility
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:…
FDA Serves Four Drugmakers With Form 483s on GMP Concerns
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
FDA Letters Slam Four Compounders Over Sterility, Prescription Issues
Four compounders recently received FDA warning letters that faulted them over sterility concerns and other issues. Source: Drug GMP Report
Xellia, FDA Modify Consent Decree; Site Can Resume Production by 2017
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…
FDA Targets Five Supplement Makers on Claims, Batch Production Records
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…