# FDA 483 - Angiplast Private Limited - January 30, 2020

Source: https://www.keypedia.com/records/483/angiplast-private-limited/686c9eb9-54a9-4fa9-9e7e-f00b600127ad

> FDA 483 for Angiplast Private Limited on January 30, 2020. Product: device. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Angiplast Private Limited
- Inspection Date: 2020-01-30
- Product Type: device
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: Angiplast Private Limited, a medical device manufacturer in Daskroi, India, was cited for significant quality system deficiencies during an FDA inspection. The inspection revealed failures in establishing adequate procedures for incoming product acceptance, corrective and preventive actions, purchasing controls for foreign suppliers, and equipment calibration. These issues indicate a lack of robust quality management practices impacting device quality and safety.

## Related Documents

- [WARNING_LETTER - 2020-01-30](https://www.keypedia.com/records/warning_letter/angiplast-private-limited/82e6ec99-87a4-44c1-8b00-8912ba773b94)

## Related Officers

- [Consultant](https://www.keypedia.com/people/seema-singh/7f3f7209-1749-46ee-8829-f305c5512e38)

Company: https://www.keypedia.com/companies/angiplast-private-limited/4c0a40cd-74d5-4d59-abb5-64fc1323e37f

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