FDA EIR - Letco Medical LLC - May 20, 2019

Letco Medical, LLC, an active pharmaceutical ingredient (API) repackager and relabeler in Decatur, AL, underwent a directed FDA inspection from May 6 to May 20, 2019. Conducted under the Opioid Quality Survey and guided by ICH Q7 Good Manufacturing Practice for APIs, the inspection covered API receiving, glycerin testing, complaint handling, product returns, supplier complaints, and labeling. While no formal FDA 483 observations were issued, several significant issues were verbally discussed with management, who committed to addressing them.

Key concerns included the firm's practice of assigning National Drug Codes (NDCs) to non-drug products, raising misbranding concerns under 21 CFR 207.37(a). Inconsistencies in "intended use" statements on product labeling, lacking a defined procedure, were also noted. Quality control was cited for inadequately controlled spreadsheets used for complaint and identification number tracking, specifically lacking revision history and secondary review. Additionally, the company's container closure equivalency program was found to not be regularly evaluated for ongoing compliance with current USP guidance. Management acknowledged these observations and promised corrective actions to ensure regulatory compliance.