# FDA 483 - Oxalis Labs - March 14, 2025

Source: https://www.keypedia.com/records/483/oxalis-labs/732aac14-eb14-4d67-b391-0957b77ae24a

> FDA 483 for Oxalis Labs on March 14, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Oxalis Labs
- Inspection Date: 2025-03-14
- Product Type: drugs
- Office Name: Office of Inspections and Investigations
- Summary: Oxalis Labs, a finished drug product manufacturer in Baddi, India, was cited for significant deficiencies during an FDA inspection. The firm failed to maintain critical production and testing records, implement adequate control procedures for manufacturing process changes, and thoroughly investigate unexplained discrepancies and equipment malfunctions. Additionally, manufacturing equipment was not properly evaluated for design, cleaning, and maintenance, indicating systemic issues in quality control and record-keeping.

## Related Documents

- [483 - 2019-08-02](https://www.keypedia.com/records/483/oxalis-labs/8b9b4378-e8d2-4a71-aeca-bab25b566f94)
- [483 - 2023-06-02](https://www.keypedia.com/records/483/oxalis-labs/552cbaa6-34c7-4028-8967-c1abd47b2a83)

## Related Officers

- [Miral B. Patel](https://www.keypedia.com/people/miral-b-patel/46c25f1b-e73f-4a19-b05e-d44152a00773)
- [Investigator](https://www.keypedia.com/people/guerlain-ulysse/aeef6f71-43b1-4116-b563-8bb3f2966d6a)

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

Office: https://www.keypedia.com/offices/office-of-inspections-and-investigations/7dd0b904-a3df-46bc-a7b2-70ddb6f809c8