FDA WARNING_LETTER - Apia Enterprise Inc - November 30, 2011

On June 28, 2012, the FDA issued a Warning Letter to Apia Enterprise Incorporated, following a November 29-30, 2011 inspection. The firm, which imports and distributes soft contact lenses (classified as devices), was cited for significant violations.

The soft contact lenses were deemed misbranded under section 502(t)(2) of the Act due to the firm's failure to develop, maintain, and implement adequate Medical Device Reporting (MDR) procedures, as required by 21 CFR 803.17. The firm's submitted "Complaint and MDR Procedure" was inadequate, lacking evidence of implementation (e.g., approval dates), failing to establish internal systems for timely identification and evaluation of reportable events (e.g., definitions of reportable events), and not clarifying who makes reportability decisions or how to ensure timely transmission of complete MDRs (e.g., information for FDA Form 3500A, submission address, calendar days for reporting). The procedure also incorrectly referenced baseline reports and annual certifications, which are not applicable to importers.

Additionally, the devices were misbranded under section 502(f)(1) because their labeling lacked adequate directions for use. The labeling was paraphrased, incomplete, and inaccurate, specifically missing a professional fitting guide, patient care instructions (cleaning, disinfection, wearing schedules), and specific precautions or warnings (e.