# FDA WARNING_LETTER - Oncology Tech, LLP - June 02, 2008

Source: https://www.globalkeysolutions.net/records/warning_letter/oncology-tech-llp/693697ee-8bc2-4aac-a360-146b850301da

> FDA WARNING_LETTER for Oncology Tech, LLP on June 02, 2008. Product: Devices. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Oncology Tech, LLP
- Inspection Date: 2008-06-02
- Product Type: Devices
- Office Name: Dallas District Office
- Summary: 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))

## Related Officers

- [District Director](https://www.globalkeysolutions.net/people/reynaldo-rodriguez/6e765ccb-f28d-433b-85cb-eafb8b8c35df)

Company: https://www.globalkeysolutions.net/companies/oncology-tech-llp/9ab3124b-3f63-4755-a17e-00de7138502f

Office: https://www.globalkeysolutions.net/offices/dallas-district-office/2d1ee9ae-c44c-4494-8186-a920a69b98f9