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Johnson & Johnson said its operating companies take “a variety of approaches” to identify counterfeit products, including product and packaging security steps that help distinguish authentic and counterfeit products. Read More
The firm had not defined, documented or implemented design control procedures that addressed design input, outputs, review, verification, validation or design changes, according to the nine-item 483. Read More
Devicemakers will need to include in their license applications performance testing data that “clearly demonstrates that the infusion pump can… Read More