Jagsonpal Pharmaceuticals Ltd.
Form 483 issued April 3, 2024 · Bhiwadi, India
- Inspection
- Mar 12 – Apr 3, 2024
- Investigator
- Dipesh K. Shah
- Observations
- 4
- Pages
- 3
- FEI number
- 3004153045
In short: On April 3, 2024, FDA issued a Form 483 with 4 observations to Jagsonpal Pharmaceuticals Ltd. in Bhiwadi, Rajasthan (FEI 3004153045) after an inspection that ran Mar 12 – Apr 3, 2024. The investigator was Dipesh K. Shah. Most observations concern laboratory controls and quality system.
At a glance
Laboratory controls and quality system account for 3 of 4 observations.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Records for manufacturing of EE sp are not available to Investigator for…
- 02
Your firm did not conduct a verification process for…
- 03
Deviations from written test procedures and laboratory mechanisms are…
- 04
Batch Manufacturing Records (BMR) for the manufacturing of (Ise are inadequate because BMRs…
This inspection in context
Dipesh K. Shah
29 documents · 2006–2026
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in India.
The firmJagsonpal Pharmaceuticals Ltd. history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.180
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Jagsonpal Pharmaceuticals Ltd.?
FDA listed 4 observations on this Form 483, mostly about laboratory controls, quality system and production. The opening words of each observation are shown on this page.
Who inspected Jagsonpal Pharmaceuticals Ltd.?
Dipesh K. Shah is named on this Form 483, for the inspection of Mar 12 – Apr 3, 2024. Each investigator has a profile showing what they cite most.
When was Jagsonpal Pharmaceuticals Ltd. inspected by FDA?
The inspection ran Mar 12 – Apr 3, 2024, and the Form 483 is dated April 3, 2024.
How do I get the full Form 483 for Jagsonpal Pharmaceuticals Ltd.?
Download the original PDF from FDA Intel for $99, with no subscription. Your first Form 483 or letter is on us. You also get an invoice PDF with the order.