FDA EIR - C. O. Truxton Inc. - June 01, 2017

An FDA inspection of C. O. Truxton Inc., a medical product distributor and limited repacker in Bellmawr, NJ, was conducted from April 17 to June 1, 2017. Initiated by a consumer complaint regarding Phenobarbital 30mg tablets mislabeled as 15mg, the inspection revealed numerous Current Good Manufacturing Practice (cGMP) violations, primarily focusing on drug repackaging operations under Compliance Program Guidance Manuals 7356.002 and 7356.002B.Key deficiencies included a lack of a quality control unit (a repeat observation), absence of GMP training, and no written procedures for consumer complaint handling or product recalls. Significant issues were also found in packaging and labeling systems, such as inadequate controls over materials, lack of receipt/rejection records, insufficient label storage and destruction of obsolete labels, and absence of packaging records or label reconciliation. The facility lacked spatial separation for repackaging and proper lighting. Material system deficiencies included inadequate lot traceability and failure to follow receiving/shipping procedures. Furthermore, the company was not registered with the FDA for repackaging operations and lacked a stability program for repackaged products. As a result of these findings, the firm initiated a voluntary recall of Phenobarbital Tablets (all strengths) and one lot of Amitriptyline Tablets due to insufficient packaging records and stability data. The company was issued an FDA-483 for these deficiencies, with management indicating intent to respond.