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Alt Medical Devices’ Miami, Florida plant lacked procedures to control labeling activities and procedures for maintaining device history records to show that its devices were re-labeled and re-packaged according to specifications, FDA investigators found. Read More
Lax process validation, inadequate control of nonconforming product and failure to implement CAPA procedures were a few of the concerns the FDA highlighted during an inspection of Mark Two Engineering’s Miami Lakes, Florida facility. Read More
Procedures for finished device acceptance, design control and acceptance activities for contract manufacturers were not in place, the agency said. Read More
An FDA inspection of Highland Industries’ Cheraw, South Carolina facility uncovered numerous quality system deficiencies including missing validation and manufacturing records and test reports, along with a slew of other documentation failures. Read More