# FDA WARNING_LETTER - TALON, an S & S Technology Company - March 28, 2019

Source: https://www.globalkeysolutions.net/records/warning_letter/talon-an-s-s-technology-company/9249a859-adcb-4626-af9a-e7aade10b26b

> FDA WARNING_LETTER for TALON, an S & S Technology Company on March 28, 2019. Product: Devices. Access full analysis and detailed observations.

---

## Details

- Record Type: WARNING_LETTER
- Company Name: TALON, an S & S Technology Company
- Inspection Date: 2019-03-28
- Product Type: Devices
- Office Name: Office of Medical Device and Radiological Health Operations (Division 1)
- Summary: On August 2, 2019, the FDA issued a Warning Letter to TALON, an S&S Technology Company, following an inspection from March 11-28, 2019. The inspection revealed that TALON, a manufacturer of Class I & II medical devices, had adulterated devices due to non-conformity with Quality System (QS) regulation (21 CFR Part 820).

Key violations include:
1. **Failure to document CAPA activities and results (21 CFR 820.100(b))**: CAPAs were closed without verifying corrective actions, e.g., for internal audit effectiveness, risk analysis completion, and updated job descriptions.
2. **Failure to establish design change procedures (21 CFR 820.30(i))**: Design changes were implemented without documented verification or validation, specifically for the Class II VAC-FIX System.
3. **Failure to control nonconforming product (21 CFR 820.90(a))**: Procedures lacked requirements for evaluating nonconformances and initiating investigations, a repeat observation from 2011.
4. **Failure to maintain device history records (21 CFR 820.184)**: No batch records or lot/batch numbers for sub-components, and approximately 1,000 Class II VAC-FIX Systems lacked UDI numbers or production

## Related Officers

- [Clifton Wall](https://www.globalkeysolutions.net/people/clifton-wall/99f8e3d0-cb31-4a89-b7de-8d1e8faea35d)
- [Program Division Director](https://www.globalkeysolutions.net/people/shari-j-shambaugh/aaea1185-eca8-41f8-bec7-d5d0024b582d)

Company: https://www.globalkeysolutions.net/companies/talon-an-s-s-technology-company/333032cf-6910-43d5-babf-4fab51163664

Office: https://www.globalkeysolutions.net/offices/office-of-medical-device-and-radiological-health-operations-division-1/c2b03748-4c7c-4f76-b2ea-bc8f47e6e7f2