AARTI PHARMALABS LIMITED
Form 483 issued June 23, 2022 · Thane, India
- Inspection
- Jun 21 – Jun 23, 2022
- Investigator
- Gam S. Zamil
- Observations
- 2
- Pages
- 2
- FEI number
- 3007005296
In short: On June 23, 2022, FDA issued a Form 483 with 2 observations to AARTI PHARMALABS LIMITED in Thane, Maharashtra (FEI 3007005296) after an inspection that ran Jun 21 – Jun 23, 2022. The investigator was Gam S. Zamil. Most observations concern materials and laboratory controls; the most-cited regulation is 21 CFR 211.142 (warehousing procedures).
At a glance
Materials and laboratory controls account for 2 of 2 observations.
Most cited: 21 CFR 211.142 (1×) · 211.194 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Intermediate drug products are not stored under appropriate conditions of temperature so that their identity, strength…
- 02
Analytical Test methods were not transferred from the © @)) sponsor…
This inspection in context
Gam S. Zamil
18 documents · 2016–2024
Cites 211.166 (stability testing) more than any other section. Most of their documents are for sites in New York.
The firmAARTI PHARMALABS LIMITED history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.142
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at AARTI PHARMALABS LIMITED?
FDA listed 2 observations on this Form 483, mostly about materials and laboratory controls. The most-cited regulation is 21 CFR 211.142 (warehousing procedures). The opening words of each observation are shown on this page.
Who inspected AARTI PHARMALABS LIMITED?
Gam S. Zamil is named on this Form 483, for the inspection of Jun 21 – Jun 23, 2022. Each investigator has a profile showing what they cite most.
When was AARTI PHARMALABS LIMITED inspected by FDA?
The inspection ran Jun 21 – Jun 23, 2022, and the Form 483 is dated June 23, 2022.
How do I get the full Form 483 for AARTI PHARMALABS 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.