Market Overview

Stratus Pharmaceuticals Responds to Misinformation In the Aftermath of FDA Consent Agreement

Share:





In order to clarify misinformation disseminated as a result of the
Consent Decree entered by the Southern District of Florida, and to which
Stratus Pharmaceuticals agreed, Stratus advises that its decision to
enter into that agreement was strictly economic – and in no way an
admission of the specific allegations in the FDA's Complaint.

In fact, none of the allegations in the Complaint have been established
by testimony or evidence, and many are factually inaccurate. For
example, Alberto Hoyo was never the President or CEO of Sonar Products
Inc., as the Complaint claims. The inspections that led to this
enforcement action took place during the tenure of Sonar's former
president, who was terminated. He was replaced by a highly qualified and
experienced executive in the industry.

It is important to point out the following items in this Consent Decree:

1. There is NO recall for any of Stratus' products.

2. Stratus' Miami Gardens manufacturing facility continues to operate
without any interruptions in conformance with the Federal Food, Drug and
Cosmetic Act.

3. There will be NO interruptions in manufacturing and shipping
of Stratus' products.

4. The Stratus Distribution Center in Miami continues to operate without
any disruptions.

5. Stratus discontinued the manufacturing and distribution of unapproved
products.

It should be noted that the FDA did not act with any urgency on this
matter. Their action was based on inspections that took place more than
two years ago. Also, since the inspections in 2015, the FDA never
returned to Stratus or Sonar to conduct additional inspections. There
were never any subsequent negative findings. On the contrary,
independent auditors agreed that both facilities were in substantial
compliance with current good manufacturing practice (CGMP) requirements.

"We are looking forward, not backwards," said Mr. Hoyo. "We agreed to
the terms of the Consent Decree only in order to close the chapter of
its association with Sonar."

Stratus has moved all of its production to a state-of-the-art facility
in South Florida where it will continue to produce and distribute the
highest-quality products for its longstanding clients.

ABOUT STRATUS

Stratus Pharmaceuticals, Inc. operates as a pharmaceutical company that
provides dermatology, plastic surgery, wound care, and podiatry products.

View Comments and Join the Discussion!