Sunrise Pharmaceutical, Inc. – FDA Warning Letter, Jul 17, 2009

The FDA issued a Warning Letter to Sunrise Pharmaceutical, Inc. following a June 19 to July 17, 2009 inspection of their Rahway, New Jersey facility, identifying significant Current Good Manufacturing Practice (CGMP) violations and the manufacture of unapproved and misbranded drugs.

CGMP violations include: 1. **Inadequate Laboratory Controls (21 CFR 211.160(a)):** Failure to investigate out-of-specification (OOS) humidity levels and back-dating service requests. Quality Unit approval for corrective actions and product disposition occurred before inspection completion. This is a repeat observation from 2007. 2. **Inadequate Production and Process Controls (21 CFR 211.100(a)):** Validation studies for Guaifenesin and Dextromethorphan HBr Caplets were insufficient, with one validation lot failing blend uniformity and being re-blended without Quality Unit approval. The validation protocol was approved after manufacturing. 3. **Inadequate Master Production and Control Records (21 CFR 211.186(b)(4)):** Use of excess active pharmaceutical ingredients (API) without scientific justification or documentation of "process loss." 4. **Inadequate Stability Testing Program (21 CFR 211.166(a)(3)):** Failure to develop and validate stability-indicating test methods for some products (e