FDA WARNING_LETTER - Pharmaceutical Innovations, Inc. - May 05, 2011

This FDA Warning Letter, dated November 21, 2011, addresses Pharmaceutical Innovations, Inc. following an inspection from April 14 to May 5, 2011. The inspection found that the firm's devices, including Ultra Phonic Conductivity Gel and Ultra Phonic Fontanelle Scanning Pad, were adulterated under 21 U.S.C. § 351(h) due to non-conformity with Current Good Manufacturing Practice (CGMP) requirements of the Quality System (QS) regulation (21 CFR Part 820).

Key violations include: 1. **Failure to establish and maintain procedures for finished device acceptance (21 CFR 820.80(d))**: Specifically, no documented procedures for final inspection and testing of Ultra Phonic Conductivity Gel for sterility. 2. **Failure to establish and maintain equipment calibration procedures (21 CFR 820.72)**: Dry heat sterilizers used for sterile products were not routinely calibrated, inspected, or maintained. 3. **Failure to identify actions for corrective and preventive action (CAPA) (21 CFR 820.100(a)(3))**: No CAPA initiated for MDR complaint 742 regarding Pseudomonas contamination in ultrasound gel, with the firm's investigation inadequately concluding improper product use without identifying recurrence prevention actions. 4. **Failure to maintain Device Master Records