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Press Release

Stratus Pharmaceuticals Announces Results Of FDA Inspection To Stratus's Distribution Center

Stratus Pharmaceuticals
Posted on: 24 Jun 18

MIAMI, June 20, 2018 /PRNewswire/ -- Stratus Pharmaceuticals has received correspondence from the FDA indicating the Establishment Inspection Report (EIR) results of the inspection that took place during 03/06/2018 to 03/08/2018 , showing that there were no 483 Items and as such, the inspection is closed.

It was also noted in the FDA's EIR communication to Stratus that the deficiencies encountered by the FDA during the inspections dated 11/18-21/2014 and 12/02-08/2014 have all been corrected.

Mr. Hoyo commented that this is another milestone in the continued growth and development of Stratus and represents another positive result for the Company following the FDA inspection of Tarmac, Stratus's wholly owned manufacturing facility in Miami Gardens, Fla.

After completion of the Tarmac inspection, the FDA sent the Company communication in which, not only approved this facility as being compliant with GMP (good manufacturing practices), but also cleared the company to prepare and apply to the FDA for NDA's (new drug applications) and ANDA's (abbreviated new drug applications), as appropriate.

Stratus will continue bringing quality economical alternative to the Dermatology and Wound Care Markets.

Editor's Details

Mike Wood

Last updated on: 24/06/2018

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