FDA WARNING_LETTER - AMD Global Telemedicine, Inc. - August 03, 2017

On November 14, 2017, the FDA issued a Warning Letter to TELEMED, a manufacturer of diagnostic ultrasound systems in Vilnius, Lithuania, following an inspection from July 31 to August 3, 2017. The inspection revealed that TELEMED's devices are adulterated because their manufacturing, packing, storage, or installation methods do not conform to the Quality System (QS) regulation (21 CFR Part 820).

The letter details 18 violations, including failures in establishing and maintaining adequate procedures for: 1. **Design Plans (21 CFR 820.30(b)):** No design plan for the MicrUS Ultrasound Imaging System, citing confidentiality. 2. **Design Input (21 CFR 820.30(c)):** Ambiguous and incomplete design inputs for MicrUS, with missing safety requirements. 3. **Design Output (21 CFR 820.30(d)):** No documented evidence of conformance evaluation of design outputs to input requirements. 4. **Design Review (21 CFR 820.30(e)):** Sporadic design reviews for MicrUS, lacking formal planning, stage identification, and independent reviewers. 5. **Design Verification (21 CFR 820.30(f)):** Inadequate documentation of MicrUS design verification, lack