Oncology Tech, LLP – FDA Warning Letter, Jun 2, 2008

Oncology Tech, LLP, a specification developer of Mod 1 Compensators (milled brass blocks for radiation therapy), received an FDA Warning Letter following an inspection from May 20-29 and June 2, 2008. The inspection revealed the devices are adulterated under 21 U.S.C. § 351(h) due to non-conformity with Current Good Manufacturing Practice (CGMP) requirements of the Quality System (QS) regulation (21 C.F.R. Part 820).

Key violations include: 1. **Failure of management with executive responsibility** to ensure an adequate and effective quality system (21 C.F.R. § 820.20), specifically lacking procedures for quality audits, complaint handling, MDR reporting, purchasing controls, design controls, CAPA, acceptance activities, and software validation. 2. **Inadequate design controls** (21 C.F.R. § 820.30(a), (b), (i), (j)), including no written procedures for design control processes, no design and development plan, no procedures for design change approval (e.g., unvalidated use of 6061 aircraft-grade aluminum), and no comprehensive design history file. 3. **Insufficient process controls** (21 C.F.R. § 820.70(a))