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Lusys Laboratories in San Diego, Calif., failed to establish design control procedures and ensure that equipment met specifications, the FDA said, in a Form 483. Read More
Isolux received a Form 483 for not adequately establishing procedures for quality audits, for not implementing a supplier evaluation procedure, and other observations. Read More
The FDA hit Guangdong, China-based Implant Dental Technology with a warning letter citing equipment contamination, production deficiencies, and other violations. Read More