# FDA 483 - Flextronics Romania Srl - May 11, 2017

Source: https://www.keypedia.com/records/483/flextronics-romania-srl/5c62c532-3a27-43c0-a175-bd074a549467

> FDA 483 for Flextronics Romania Srl on May 11, 2017. Product: other. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Flextronics Romania Srl
- Inspection Date: 2017-05-11
- Product Type: other
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: An FDA inspection of Flextronics Romania Srl, a manufacturer in Timisoara, Romania, identified one significant observation. The firm's procedures for accepting incoming product were found to be inadequately established. Specifically, the company failed to inspect incoming materials, such as Luer Lock Connectors and PVC Tubes, using the correct sample sizes as required by their own Station Instruction Card and ANSI/ASQC Z1.4 standards.

## Related Officers

- [Stephen R. Souza](https://www.keypedia.com/people/stephen-r-souza/9b7af4df-f1cc-468d-9761-cee11d3c14fc)

Company: https://www.keypedia.com/companies/flextronics-romania-srl/e610a2af-4b61-4e60-bda3-01b82f15bba3

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