Contract drugmaker Izeen Pharma of Frederick, Maryland, drew a 21-page Form 483 from the FDA for numerous deficiencies, including inadequate validations and poor data handling. Read More
The FDA issued a warning to CustomRX of Wichita, Kansas, for serious deficiencies identified during an inspection of its compounding facility, including inadequate cleanroom conditions and product testing. Read More
Procedures for submitting medical device reports to the FDA, as well as inadequate CAPA procedures were among the numerous quality system failures uncovered during a Jan. 29 to Feb. 1 inspection of Beijing Polycon Medical Engineering’s p... Read More
Failure to establish a design history file or to put procedures in place to control device history records, in addition to failure to conduct quality reviews, landed devicemaker LSVT Global a 10-item Form 483 following a July 16 to July ... Read More
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