# FDA 483 - Oxalis Labs - August 02, 2019

Source: https://www.globalkeysolutions.net/records/483/oxalis-labs/8b9b4378-e8d2-4a71-aeca-bab25b566f94

> FDA 483 for Oxalis Labs on August 02, 2019. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Oxalis Labs
- Inspection Date: 2019-08-02
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: Oxalis Labs, a drug manufacturer in Theda, India, was inspected by the FDA from July 29 to August 2, 2019. The inspection revealed significant issues with personnel adequacy for drug product processing and a failure to consistently investigate unexplained discrepancies, particularly regarding late stability sample testing. These observations indicate a lack of robust quality control and personnel management.

## Related Documents

- [483 - 2023-06-02](https://www.globalkeysolutions.net/records/483/oxalis-labs/552cbaa6-34c7-4028-8967-c1abd47b2a83)

## Related Officers

- [Consumer Safety Officer](https://www.globalkeysolutions.net/people/jeffrey-p-raimondi/7576ca4e-d9e8-4015-9ae6-9498e76058d3)

Company: https://www.globalkeysolutions.net/companies/oxalis-labs/bc19741c-c2c0-43bc-80ad-91eda4acf921

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