Lehigh Valley Technologies, Inc. – FDA Warning Letter, Feb 3, 2011

This FDA Warning Letter, dated July 15, 2011, was issued to Lehigh Valley Technologies, Inc. following an inspection from January 10 to February 3, 2011. The inspection identified significant violations of Current Good Manufacturing Practice (CGMP) regulations for Finished Pharmaceuticals (21 CFR Parts 210 and 211), rendering the firm's drug products adulterated. The firm's February 23, 2011, response was deemed inadequate, and a March 9, 2011, response was not considered due to late submission.

Key violations include: 1. **Inadequate Production and Process Control Procedures (21 CFR § 211.100(a))**: The Quality Control Unit (QCU) altered acceptance criteria to approve an Oxycodone HCl 5mg tablet validation lot that failed blend uniformity. Insufficient samples were collected for blend uniformity and dosage unit in-process testing. 2. **Insufficient Investigation of Out-of-Specification (OOS) Results (21 CFR § 211.192)**: The QCU released Morphine Sulfate Oral Solution 20mg/ml batches despite OOS bulk assay results and inadequate investigations failing to identify a discernable cause or address quality system failures in repeat testing. 3. **Lack of Reprocessing Procedures (21 CFR § 211