Contract Manufacturer Swabplus Warned To Remediate Water, Computer Systems
Maker of single-dose topical swabs indicated for application to sores and open wounds asked o respond with information including a "thorough remediation plan to install and operate a suitable water system." FDA inspectors determined Swabplus didn't correct problem found in a 2016 inspection of failing to test incoming components.
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So full of errors were the firm's online ads for its Plavinol supplement, the National Advertising Division noted support for some claims contained "many of the same flaws" as others. The prevalence of problems prompted NAD to go outside its "scope of review" and note unclear instructions on Plavinol labels.
Perrigo "walked away a little bit" from "a model that worked beautifully," says CEO Murray Kessler at investor conference, "In essence, all we've done over the last year is to put back in place the model that worked so well."