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An active pharmaceutical ingredient (API) maker was chided by the FDA for not keeping batch records, as well as not investigating out-of-specification results or performing full testing on products. Read More
FDA officials sought to clarify how the agency’s authority to punish drugmakers for obstructing facility inspections applies to such issues as divulging trade secrets, accessing emails and translating documents into English. Read More
A slew of leaky, deteriorating products, an insect infestation and poor complaint handling resulted in another Form 483 for beleaguered injectables giant Hospira. Read More
More than a year after being warned by the FDA for poor quality, Alexion Pharmaceuticals received a fresh Form 483 for problems surrounding gowning procedures and other quality issues. Read More
Compounding pharmacies are asking the FDA to overhaul its guidance for interim good manufacturing practices, contending the recommendations for such things as the cleanliness of air filters and presence of particulates are unclear and subjective. Read More
A Chinese active pharmaceutical ingredient (API) maker was slammed by the FDA for falsifying batch record signoffs and product labeling, the latest international drugmaker to be caught in the agency’s crackdown on poor data integrity. Read More
Indian regulators have issued a uniform set of procedures that state drug authorities should follow when inspecting plants for GMPs and issuing certificates of pharmaceutical product (COPP) that clear drugs for export. Read More
Impax received two Form 483s less than a week apart for poor inspections of two manufacturing facilities, igniting fresh doubts on the company’s plan to win approval of its Parkinson’s drug Rytary. Read More
The FDA has cited two compounding pharmacies for making unapproved and contaminated drugs, and for poor sterile processing practices, the latest indication that the agency won’t let up on larger facilities. Read More
The FDA was not happy that Elite Laboratories’ quality unit failed to validate and review various product batches before distribution, landing the generic drug maker a Form 483. Read More
The FDA slapped positron emission tomography (PET) drug manufacturer Cardinal Health with a Form 483 for poor data integrity and investigations into quality problems. Read More
Marcus Research Laboratory was handed a Form 483 for not performing stability testing or properly monitoring the production process for the active pharmaceutical ingredient iodine. Read More