FDA 483 - Summerton Drug Compounding and Dispensary - October 17, 2014

The FDA Form 483 identifies multiple violations at a drug manufacturing facility. The firm failed to thoroughly investigate potency failures in three lots of CBDC1-A Cream (Lots 1112013(8)1, 01312014(8)4, 04182014(8)4) for Baclofen (84.1%-114.1%), Cyclobenzaprine HCl (88.8%), Diclofenac Sodium (89.0%-98.1%), and Lidocaine (82.8%-99.8%). This violates SOP 9.060 and USP 1201. The firm's procedures (SOP 9.150, SOP 9.060) lack acceptance criteria for finished product testing, contradicting SOP 9.140 which references USP monograph criteria.

The written stability testing program is not followed, as there is no stability data to support the 90-day Beyond Use Dates (BUDs) assigned to products like CBDC1-A Cream, KBCG1-F Cream, DBCG1-Li Cream, and TDCTG Cream, violating SOP 9.050. Batch production records for these products are incomplete, lacking accurate mixing times and specific details. Written production and process control procedures, specifically SOP 9.140,