# FDA 483 - Element Materials Technology Canada Inc. - September 20, 2019

Source: https://www.globalkeysolutions.net/records/483/element-materials-technology-canada-inc/ef379147-6ebc-4714-b6c4-8327f614c4f0

> FDA 483 for Element Materials Technology Canada Inc. on September 20, 2019. Product: drugs. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Element Materials Technology Canada Inc.
- Inspection Date: 2019-09-20
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: An FDA inspection of Lupin Limited, an API manufacturer in Tarapur, India, revealed significant quality control deficiencies. These included inadequate investigations into metal particle contamination, incomplete batch production records, and improper storage of cleaned equipment and utensils. The findings indicate a need for improved manufacturing practices and adherence to regulatory standards.

## Related Documents

- [483 - 2019-10-18](https://www.globalkeysolutions.net/records/483/element-materials-technology-canada-inc/22857589-3e65-4658-adc8-de72d91c3b07)

## Related Officers

- [Investigator](https://www.globalkeysolutions.net/people/unnee-ranjan/43f1d07e-4079-4d33-88a9-baf6a5df932c)

Company: https://www.globalkeysolutions.net/companies/element-materials-technology-canada-inc/c806fa60-ad44-4fcb-8287-fcb954bcbcf4

Office: https://www.globalkeysolutions.net/offices/office-of-biological-products-operations-division-i/49c53dac-7724-4c8c-8708-4f5779ea69c1