FDA 483 - Vils Pharma Coating, LLC - November 21, 2024

During an FDA inspection conducted from November 15 to November 21, 2024, Vils Pharma Coating, LLC received a Form 483 detailing significant observations that indicate potential non-compliance with Current Good Manufacturing Practices. The inspection revealed critical deficiencies across several key areas of their manufacturing operations. The company was cited for failing to complete equipment qualification for shared equipment utilized in the production of various Over-The-Counter (OTC) drug products. Inadequate cleaning and maintenance practices were also observed, with visible corrosion, rust-like residues, and dust accumulation on manufacturing equipment, coating pans, mixers, and facility surfaces like floors and walls in processing areas, which were not smooth or easily cleanable.

Furthermore, laboratory controls were found to be insufficient, lacking a scientifically sound, risk-based testing schedule and rationale for their water system, along with undefined routine water sample points. The firm also lacked essential written standard operating procedures for critical GMP topics, including manufacturing process validation, equipment qualification, equipment identification numbering, and overall GMP documentation control. Additionally, procedures for controlling logbooks and conducting temperature mapping were absent. Addressing these observations is crucial for Vils Pharma Coating, LLC to ensure adherence to regulatory standards and uphold the quality and safety of their drug products.