# FDA 483 - TAMPON INNOVATIONS  LTD. - July 11, 2024

Source: https://www.keypedia.com/records/483/tampon-innovations-ltd/274fff28-5772-4e3f-9816-7768a9eb8e3b

> FDA 483 for TAMPON INNOVATIONS  LTD. on July 11, 2024. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: TAMPON INNOVATIONS  LTD.
- Inspection Date: 2024-07-11
- Product Type: device
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: TAMPON INNOVATIONS, a manufacturer in Iliyantsi, Bulgaria, was inspected and cited for significant deficiencies in its complaint handling procedures. The firm failed to establish adequate processes for evaluating complaints for medical device reporting (MDR), including serious adverse events like toxic shock syndrome, and did not properly document complainant information. These issues indicate a lack of robust quality system controls for post-market surveillance.

## Related Officers

- [Sunita Pandey](https://www.keypedia.com/people/sunita-pandey/008e5bb8-0eb3-45d8-8524-734ac0454250)

Company: https://www.keypedia.com/companies/tampon-innovations-ltd/6751e525-156e-4515-bfdf-a122ae892162

Office: https://www.keypedia.com/offices/division-of-clinical-evidence-and-analysis-1-clinical-policy-and-quality/5f95da17-30bb-423f-b892-5ea041823fbd