Automated Ophthalmics, Inc. – FDA Warning Letter, Mar 19, 2013

On June 5, 2013, the FDA issued a Warning Letter to Automated Ophthalmics, Inc. following an inspection from February 26 to March 19, 2013. The inspection revealed that the firm's Softips brand tip covers for the Mentor Tonopen are adulterated under 21 U.S.C. § 351(h) because manufacturing, packing, storage, or installation methods do not conform to Quality System (QS) regulation (21 CFR Part 820). The products are also misbranded under 21 U.S.C. § 352(t)(2) for failing to provide required information under 21 U.S.C. § 360i and 21 CFR Part 803 (Medical Device Reporting).

Key violations include: 1. **Failure to establish and maintain adequate design control procedures (21 CFR 820.30(a))**: No design control procedures for Softips, including design plan, inputs, outputs, reviews, verification, validation, or history file. The firm's response was inadequate due to a lack of timeframes and interim actions. 2. **Failure to inspect, test, or verify incoming product (21 CFR 820.80(b))**: Incoming latex tips were not properly inspected or tested. For example, lot 2