FDA 483 - Pharmco Laboratories Inc. - September 22, 2021

Pharmco Laboratories Inc. in Titusville, FL, was inspected and received a Form 483 with 10 observations, indicating significant deficiencies in their drug manufacturing operations. The inspection revealed widespread issues including inadequate equipment cleaning and maintenance, poor facility upkeep, insufficient process and water system validations, and failures in quality control. Additionally, problems were identified with laboratory controls and the proper management of drug product reserve samples.