FDA 483 - Piedmont LLC - May 09, 2025

Piedmont LLC, a drug and cosmetic manufacturer in Gainesville, GA, was cited for failing to follow written production and process control procedures. Inspectors observed multiple logbooks in poor condition, including wet, smeared, illegible, and incomplete entries, indicating a failure to maintain records according to the firm's Standard Operating Procedure. This suggests significant issues with documentation and adherence to established quality controls.