# PRITAM INTERNATIONAL PRIVATE LIMITED – FDA 483, Jun 2, 2026

Source: https://www.keypedia.com/records/483/pritam-international-private-limited/6513d865-0bbe-48d7-9b9d-fa943565d73a

> FDA 483 for PRITAM INTERNATIONAL PRIVATE LIMITED on June 02, 2026. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: PRITAM INTERNATIONAL PRIVATE LIMITED
- Inspection Date: 2026-06-02
- Product Type: drugs
- Office Name: Office of Partnerships
- Summary: Pritam International Pvt. Ltd. in Roorkee, India, an OTC drug manufacturer, was cited for significant deficiencies during an FDA inspection. The observations highlight critical issues across laboratory controls, process validation, batch recordkeeping, equipment cleaning, and quality system oversight. These deficiencies indicate a lack of robust controls to ensure the quality, safety, and purity of their drug products.

## Related Documents

- [WARNING_LETTER - 2026-06-06](https://www.keypedia.com/records/warning_letter/pritam-international-private-limited/25cee672-1dbf-4484-a1df-be82de05006d) — date: June 6, 2026

## Related Officers

- [Owner/Inspector](https://www.keypedia.com/people/jared-p-stevens/11cd48ff-e61f-4448-98be-efe2f8377fc1)
- [Consumer Safety Officer/ Federal Investigator](https://www.keypedia.com/people/lisa-l-flores/465a6807-55d7-4c3f-a415-c21ac4517bc9)

Company: https://www.keypedia.com/companies/pritam-international-private-limited/b1bb727f-07d5-447b-ba41-354d4d2375a6

Office: https://www.keypedia.com/offices/office-of-partnerships/83acc701-fc5a-4876-bb34-7499e31541d3