# FDA WARNING_LETTER - IsoAid, L.L.C. - April 20, 2012

Source: https://www.keypedia.com/records/warning_letter/isoaid-llc/5d13b1bc-3e8b-473e-8dae-5abc9ec704ba

> FDA WARNING_LETTER for IsoAid, L.L.C. on April 20, 2012. Product: Devices. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: IsoAid, L.L.C.
- Inspection Date: 2012-04-20
- Product Type: Devices
- Office Name: Department of Health and Human Services
- Summary: On August 16, 2012, the FDA issued a Warning Letter to IsoAid, L.L.C. following an inspection from April 12-20, 2012, which found their Advantage Iodine-125™, Advantage PD-103™ Brachytherapy Seeds, and Advantage-Strand™/Advantage-Load™ Brachytherapy Kit devices to be adulterated and misbranded.

The devices were deemed 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). Violations included:
1. **Failure to validate processes (21 C.F.R. 820.75(a)):** Specifically, the EO sterilization process, heat sealer process, and BI reader were not adequately validated.
2. **Failure to control production processes (21 C.F.R. 820.70(a)):** The sterilization procedure lacked provisions for positive BI results, and investigations into nonconformances were not documented.
3. **Failure to validate computer software (21 C.F.R. 820.70(i)):** The Sorting software for decay calculations was not validated, and procedures for qualification,

## Related Officers

- [Consumer Safety Officer](https://www.keypedia.com/people/salvatore-n-randazzo/c5f4bcc1-4880-4fb0-a932-c4823503dadf)
- [District Director](https://www.keypedia.com/people/emma-r-singleton/e0b72aba-caa5-4cf8-8beb-6f93f6654e59)

Company: https://www.keypedia.com/companies/isoaid-llc/25f3713f-1404-4a6e-8348-83da74429aaa

Office: https://www.keypedia.com/offices/department-of-health-and-human-services/cecfcda4-4afa-4a1f-a7b7-a020b79f9861