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Inadequate processes for validating the facility’s water system, controlling purchased products and accepting incoming products were some of the issues flagged. Read More
A CAPA report showed manufacturing errors that led to many low patient results were caused by a failure to update manufacturing procedures after a design change, the agency said. Read More
Medical device manufacturers need access to quality benchmarking data and related FDA guidance to improve their products, says a new report from the Medical Device Innovation Consortium. Read More
What has always been implicit in the FDA’s Quality System Regulation is spelled out in detail in the 2016 version of international standard ISO 13485. Read More
Failure to establish corrective and preventive action procedures as well as procedures for receiving and reviewing complaints landed Texas-based Simpro an FDA warning letter. Read More
Certain Class II device manufacturers will get two more years to comply with the FDA’s unique device identifier rule that was scheduled to become effective Sept. 24. Read More
The FDA handed a warning letter to Tosoh Bioscience, an importer of assays and high performance liquid chromatographs, for failing to properly manage its suppliers and handle complaints. Read More