FDA EIR - Allergan Sales, LLC - February 06, 2009

An FDA Level II Quality System Inspection of Allergan Sales LLC (ASL Waco) occurred from February 2-6, 2009, carried out by the Texas Department of State Health Services under federal contract. The inspection specifically reviewed ASL Waco's manufacturing of "Refresh Contacts," a Class II sterile over-the-counter soft contact lens care product, to ensure compliance with FDA medical device regulations, ISO standards, and Canadian Medical Device Regulations. The audit thoroughly covered management, design, corrective and preventive actions, and production and process controls.

Remarkably, the inspection concluded with no formal deficiencies or "Objectionable conditions" identified, and no FDA Form 483 was issued. This outcome indicates the facility's strong adherence to regulatory requirements. Two minor verbal observations were noted during the closing conference: one obsolete document found within current records, which management committed to addressing, and a few minor clerical errors. Management promptly demonstrated a correction process for one of the clerical errors. No official required actions or voluntary corrections were documented, reflecting the minor nature of these observations. Management was fully cooperative throughout the inspection.