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The FDA handed Akron Coating & Adhesives a Form 483 for not properly testing or controlling combination drug-device products at its Akron, Ohio, facility. Read More
The FDA has issued a warning letter to Forcemech International in Pearland, Texas, after not getting a response to observations it made during an inspection from March 29 to April 4. Read More
The FDA has provided an update on Philips Respironics’ recall of almost 18.7 million masks for use with bilevel positive airway pressure (BiPAP) and continuous positive airway pressure (CPAP) machines, deeming the recall Class 1 because of the risk of serious injury or death. Read More
Insulet has sent letters to users of its Omnipod DASH insulin management system with a warning about defective batteries in the personal diabetes manager (PDM) controller device. Read More
An FDA inspection of Hill Laboratories’ Frazer, Penn., facility found problems with complaint and audit procedures as well as the design of a light therapy unit. Read More