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FDA investigators found Stimwave Technologies’ complaint handling procedures and corrective and preventive actions for its implantable pain treatment devices were not up to par, during a Jan. 29-Feb. 15 inspection of the firm’s Pompano Beach, Fla. Facility. Read More
An unregistered outsourcing facility’s failure to report details of more than 4,200 potentially serious adverse events related to compounded hormones drew the ire of CDER Director Janet Woodcock, who reminded outsourcing compounders that they must report serious adverse events to the agency. Read More
Management at Health-Chem Acquisitions failed to ensure that every functional area responsible for the design and manufacturing of hCG test strips was properly resourced for achieving quality and compliance function, the FDA said following a Jan. 17-Feb. 20 inspection of the company’s Pompano Beach, Florida plant. Read More
The FDA issued a warning letter to OTC drug manufacturer Ningbo Pulisi Daily Chemical Products in Zhejiang, China for testing violations, including failure to fully test products prior to release. Read More
Failure to establish procedures for receiving, reviewing and evaluating complaints as well as failure to report complaints and other quality management issues landed Pfizer subsidiary PF Consumer Healthcare a 10-observation, 17-page FDA form 483 following a Feb. 25 to April 4 inspection of its manufacturing plant in Atlanta, Georgia. Read More