Piramal Pharma Limited
Form 483 issued February 17, 2025 · Navi Mumbai, India
- Inspection
- Feb 17, 2025
- Investigator
- Guerlain Ulysse
- Observations
- 5
- Pages
- 10
- FEI number
- 3008763768
In short: On February 17, 2025, FDA issued a Form 483 with 5 observations to Piramal Pharma Limited in Navi Mumbai, Maharashtra (FEI 3008763768) after an inspection that ran Feb 17, 2025. The investigator was Guerlain Ulysse. Most observations concern quality system and facilities & equipment.
At a glance
3 of 5 observations on this 483 concern quality system.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
The responsibilities and procedures applicable to the quality control unit are not in…
- 02
Written records of investigation of an active pharmaceutical ingredient (API)…
- 03
Written records of investigation of an API complaint do…
- 04
The cleaning of equipment…
This inspection in context
Guerlain Ulysse
32 documents · 2016–2026
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in India.
The firmPiramal Pharma Limited history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.22
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Piramal Pharma Limited?
FDA listed 5 observations on this Form 483, mostly about quality system, facilities & equipment and production. The opening words of each observation are shown on this page.
Who inspected Piramal Pharma Limited?
Guerlain Ulysse is named on this Form 483, for the inspection of Feb 17, 2025. Each investigator has a profile showing what they cite most.
When was Piramal Pharma Limited inspected by FDA?
The inspection ran Feb 17, 2025, and the Form 483 is dated February 17, 2025.
How do I get the full Form 483 for Piramal Pharma Limited?
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.