Amstech Incorporated – FDA Warning Letter, Jun 23, 2009

This FDA Warning Letter to Amstech Incorporated, dated June 23, 2009, disapproves their quality control and testing program for all laser products. This action stems from a June 23, 2009 inspection by FDA Investigator Leo J. Lagrotte, which revealed multiple violations of the Federal Food, Drug, and Cosmetic Act, specifically Chapter V, Subchapter C - Electronic Product Radiation Control.

Key violations include: 1. **21 CFR 1010.2(c):** Failure to certify electronic products based on a testing program in accordance with good manufacturing practices, specifically lacking documented final power test results for the Aimshot HeatSeeker. 2. **21 CFR 1040.10(h)(1)(iv):** Missing required warning statement ("Caution - use of controls or adjustments or performance of procedures other than those specified herein may result in hazardous radiation exposure") in user manuals for the Aimshot HeatSeeker. 3. **21 CFR 1040.11(b):** Class IIIb products failing to comply with class limits for surveying, leveling, and alignment (SLA) laser products. The Aimshot HeatSeeker (infrared) and visible laser sights LS6800, LS8200, and LS8300 (visible) are classified as SLA products, which are limited to Class I for infrared and