# FDA 483 - Stallion Laboratories Private Limited - March 24, 2023

Source: https://www.keypedia.com/records/483/stallion-laboratories-private-limited/c60eaa32-a462-4906-a1d2-d54d902bff30

> FDA 483 for Stallion Laboratories Private Limited on March 24, 2023. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Stallion Laboratories Private Limited
- Inspection Date: 2023-03-24
- Product Type: drugs
- Office Name: Office of Inspections and Investigations
- Summary: Stallion Laboratories Private Limited in Ahmedabad, India, was cited with two observations during an FDA inspection. The firm failed to establish adequate control procedures for validating manufacturing processes, specifically regarding discrepancies in performance qualification parameters. Additionally, the inspection revealed inadequate written procedures for production and process controls, leading to potential product contamination due to poor sanitation practices by an operator.

## Related Officers

- [investigator](https://www.keypedia.com/people/marian-e-ramirez/4b718b67-fee0-488c-9354-ee366d3510ad)
- [Alan A. Rivera](https://www.keypedia.com/people/alan-a-rivera/4bec02c3-c62e-4b3a-a6ab-02c3386549bf)

Company: https://www.keypedia.com/companies/stallion-laboratories-private-limited/20b4f144-435c-4f1c-8724-5ff1dca85264

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