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Dear Mabel Cox,

The Food & Drug Administration has completed an evaluation of your firm’s corrective actions in response to our Warning Letter with CMS#513227, dated March 7, 2017. Based on our evaluation, it appears that you have addressed the violations contained in this Warning Letter. Future FDA inspections and regulatory activities will further assess the adequacy and sustainability of these corrections.

This letter does not relieve you or your firm from the responsibility of taking all necessary steps to assure sustained compliance with the Federal Food, Drug, and Cosmetic Act and its implementing regulations, or with other relevant legal authority. The Agency expects you and your firm to maintain compliance and will continue to monitor your state of compliance. This letter will not preclude any future regulatory action should violations be observed during a subsequent inspection or through other means.

Sincerely,
/S/
Daniel W. Johnson
Compliance Officer
HAF Division East 2, Philadelphia Office
Office p hone: 215.717.3746
e-mail: [email protected]

Cc (via email):
Randy F. Pack, Program Division Director, District Director ([email protected])
Robin M. Rivers, Director, Compliance Branch ([email protected])
Martin J. Guardia, Director, Investigations Branch ([email protected])
Karen S. Anthony, Supervisory Consumer Safety Officer ([email protected])