FDA WARNING_LETTER - Labotech Microscopes India Private Limited - September 12, 2013

On September 9-12, 2013, an FDA inspection of Labotech Microscopes India Private Limited in Haryana, India, revealed that their slit lamps and microscopes are adulterated under 21 U.S.C. § 351(h) due to non-conformity with Quality System (QS) regulation 21 CFR Part 820. The firm's September 23, 2013, response to the FDA 483 was deemed inadequate.

Violations include: 1. **Failure to establish and maintain procedures for finished device acceptance (21 CFR 820.80(d))**: (b)(4) out of (b)(4) Xcel 255 slit lamp testing reports showed values outside specified ranges. QSP 15, Rev. 6, lacked a mechanism for identifying non-conforming test results. The firm's response, including a revised traveler form and updated procedures, was insufficient as it did not describe a specific mechanism for identifying nonconforming product or provide evidence of evaluation for previously released Xcel 255 slit lamps with failed test results.

2. **Failure to establish and maintain procedures for design changes (21 CFR 820.30(i))**: Design changes, such as those for the mount projection lens (Nonconformance (b)(4)) and the (b