Nexgen Pharma Inc – FDA Warning Letter, May 25, 2010

The FDA issued a Warning Letter to NexgenPharma, Inc. following inspections from March 1 to May 25, 2010, at their Irvine, CA, and Colorado Springs, CO, facilities. The inspections revealed significant violations of Current Good Manufacturing Practice (CGMP) regulations (21 CFR Parts 210 and 211), rendering their drug products adulterated. Additionally, several drug products were identified as unapproved new drugs, violating section 505(a) of the Act, and misbranded under section 502(f)(1) due to inadequate directions for use.

Key CGMP violations at the Irvine facility included: 1. **Inadequate equipment cleaning and maintenance:** Lack of sufficient cleaning validation or scientific justification for cleaning procedures for numerous drug products, and no documentation for adequate cleaning of drying trays. 2. **Failure to test active ingredient strength:** Not determining the strength of individual active ingredients (e.g., (b)(4), (b)(4), (b)(4)) in finished drug products prior to release, despite adding significant overages. 3. **Unjustified deviations from procedures:** Manufacturing reduced batch sizes without adequate justification for how it did not impact product quality, relying solely on finished product testing. 4. **Unjustified component overages:** Adding overages of components (e.g., (b)(4), (b)(4),