# FDA 483 - Indus Medicare Limited - January 23, 2020

Source: https://www.keypedia.com/records/483/indus-medicare-limited/3625ac7e-7837-4d41-bbaa-f22cdcdf3f96

> FDA 483 for Indus Medicare Limited on January 23, 2020. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Indus Medicare Limited
- Inspection Date: 2020-01-23
- Product Type: device
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: An FDA inspection of Indus Medicare Limited, a medical device manufacturer in Medak District, Telangana, India, revealed significant deficiencies in its quality system. The firm failed to establish adequate procedures for design control, process validation, corrective and preventive actions, in-process product acceptance, rework of nonconforming products, and medical device reporting. These issues indicate a systemic lack of control over critical manufacturing and quality processes for their latex condoms.

## Related Documents

- [WARNING_LETTER - 2020-01-23](https://www.keypedia.com/records/warning_letter/indus-medicare-limited/08e32295-ee86-4c4a-9ba8-0048767ae7a4)

## Related Officers

- [Thai T. Duong](https://www.keypedia.com/people/thai-t-duong/59737092-2f30-43a7-b23b-36fa7f212c4a)

Company: https://www.keypedia.com/companies/indus-medicare-limited/e1ac4571-a1b1-4883-809c-811cbd9ab28a

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