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

The FDA inspected C.O. Truxton, Inc. from April 17 to June 1, 2017, identifying significant CGMP violations for finished pharmaceuticals, rendering drug products adulterated and misbranded. The firm failed to establish a quality control unit with proper authority and written procedures for production or quality unit responsibilities (21 CFR 211.22(a)). They also lacked written procedures for ensuring correct labels and packaging materials (21 CFR 211.130), leading to mislabeling of Phenobarbital tablets (30 mg labeled as 15 mg). The firm did not have adequate written procedures for handling complaints (21 CFR 211.198(a)), failing to investigate a complaint about the Phenobarbital labeling mix-up. Additionally, Truxton lacked written distribution procedures for product traceability (21 CFR 211.150(b)), making recall difficult. Finally, the firm failed to establish a written stability testing program to support expiration dates for repackaged drugs (21 CFR 211.166(a)).

The mislabeled Phenobarbital tablets (30 mg sold as 15 mg) were also deemed misbranded under sections 502(b)(2), 502(e)(1)(A)(ii), and 502(a) of the FD&C Act due to inaccurate quantity statements and false