# FDA 483 - Sivshree Medittex (India) Pvt. Ltd. - August 06, 2019

Source: https://www.globalkeysolutions.net/records/483/sivshree-medittex-india-pvt-ltd/8fd2f49e-e887-4f86-816a-78c595e863eb

> FDA 483 for Sivshree Medittex (India) Pvt. Ltd. on August 06, 2019. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Sivshree Medittex (India) Pvt. Ltd.
- Inspection Date: 2019-08-06
- Product Type: device
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: Sivshree Medittex (India) Pvt. Ltd., a contract manufacturer in Coimbatore, India, received a Form FDA 483 with three observations. The inspection revealed significant deficiencies including the absence of written Medical Device Reporting procedures, a lack of written agreements with suppliers for change notification, and inadequate procedures for equipment calibration. These findings highlight critical gaps in the firm's quality system.

## Related Officers

- [issuing_officer](https://www.globalkeysolutions.net/people/paul-m-kawamoto/0a24b110-12de-4736-8d98-7a023ceec01e)

Company: https://www.globalkeysolutions.net/companies/sivshree-medittex-india-pvt-ltd/8cff35e4-7e2d-4da9-aa39-39058d38cdba

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