!pea Labor:ator: i es Limited
Form 483 issued December 5, 2025 · Palghar, India
- Inspection
- Dec 1 – Dec 5, 2025
- Investigator
- Saleem A. Akhtar
- Observations
- 3
- Pages
- 3
- FEI number
- 3006057101
In short: On December 5, 2025, FDA issued a Form 483 with 3 observations to !pea Labor:ator: i es Limited in Palghar, Maharashtra (FEI 3006057101) after an inspection that ran Dec 1 – Dec 5, 2025. The investigator was Saleem A. Akhtar. Most observations concern facilities & equipment and laboratory controls.
At a glance
2 of 3 observations on this 483 concern facilities & equipment.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Buildings and facilities used to manufacture APis are not maintained appropriately to facilitate cleaning and…
- 02
The suitability of analytical test methods is deficient…
- 03
There is a lack of adequate controls in place to minimize the carryover ofthe residual materials…
This inspection in context
Saleem A. Akhtar
35 documents · 2004–2026
Cites 211.160 (general requirements) more than any other section. Most of their documents are for sites in India.
The firm!pea Labor:ator: i es Limited history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.42
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at !pea Labor:ator: i es Limited?
FDA listed 3 observations on this Form 483, mostly about facilities & equipment and laboratory controls. The opening words of each observation are shown on this page.
Who inspected !pea Labor:ator: i es Limited?
Saleem A. Akhtar is named on this Form 483, for the inspection of Dec 1 – Dec 5, 2025. Each investigator has a profile showing what they cite most.
When was !pea Labor:ator: i es Limited inspected by FDA?
The inspection ran Dec 1 – Dec 5, 2025, and the Form 483 is dated December 5, 2025.
How do I get the full Form 483 for !pea Labor:ator: i es 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.