Recordati Rare Diseases Inc.: Cystadrops

Drug, and Cosmetic Act for Cystadrops (cysteamine ophthalmic solution) 0.37%.

Please note that amendments submitted after November 23, 2019, were not reviewed as they were submitted late in the review cycle.

Satisfactory resolution of these deficiencies is required if this facility remains in the application.

All submitted facilities must be in compliance with cGMP before this application may be approved.

2. The methods to be used in, and the facilities and controls used for the manufacture, processing, packing and holding of the drug product are inadequate to preserve its identity, strength, quality, purity, stability or bioavailability.