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# Multiple Violations at Jagsonpal Pharmaceuticals
- URL: https://www.fdaweb.com/multiple-violations-at-jagsonpal-pharmaceuticals/
- Published: 2025-02-18T12:00:00.000Z
- Updated: 2026-09-14T14:53:26.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5158671

A 3/20-4/3/2024 FDA inspection at the Jagsonpal Pharmaceuticals drug manufacturing facility in Gurugram, Haryana, India, found significant deviations from current good manufacturing practice (CGMP) regulations for active pharmaceutical ingredients (APIs) and other violations. A 2/5 [Warning Letter](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/jagsonpal-pharmaceuticals-limited-693134-02052025?ref=fdaweb.com) says specific deviations and violations were:

- failure of the firm’s quality unit to exercise its responsibility to ensure that APIs manufactured at the contract facility comply with CGMP;
- establishment registration and drug listing violations.

The letter notes that FDA investigators attempted to inspect the company on 3/15/2024 and were denied admission. They were permitted to enter on 3/20/2024, it says, but access to requested documents was limited.

FDA recommends that Jagsonpal engage a qualified consultant to evaluate its operations and assist it in meeting CGMP requirements. The agency placed the firm’s products on a 1/17 Import Alert.

Jagsonpal was told to promptly correct any deviations and to respond with a list of specific actions it has taken to address the deviations and prevent their recurrence, with a schedule for completing the corrections.