AARTI PHARMALABS LIMITED
Form 483 issued February 20, 2020 · Tarapur, India
- Inspection
- Feb 17 – Feb 20, 2020
- Investigator
- Jason R. Caballero
- Observations
- 4
- Pages
- 3
- FEI number
- 3005256484
In short: On February 20, 2020, FDA issued a Form 483 with 4 observations to AARTI PHARMALABS LIMITED in Tarapur, Maharashtra (FEI 3005256484) after an inspection that ran Feb 17 – Feb 20, 2020. The investigator was Jason R. Caballero. Most observations concern laboratory controls and quality system; the most-cited regulation is 21 CFR 211.160 (general requirements).
At a glance
Laboratory controls and quality system account for 3 of 4 observations.
Most cited: 21 CFR 211.160 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
All specifications, sampling plans, sample storage, and test procedures should be scientifically sound and appropriate to…
- 02
The quality units should be involved in all quality-related matters. The main responsibilities of the independent…
- 03
Before incoming materials are mixed with existing stocks, they should be identified as correct, tested if…
- 04
When entries are made in records, these should be made indelibly in spaces provided for such…
This inspection in context
Jason R. Caballero
26 documents · 2014–2020
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in Texas.
The firmAARTI PHARMALABS LIMITED history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.160
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at AARTI PHARMALABS LIMITED?
FDA listed 4 observations on this Form 483, mostly about laboratory controls and quality system. The most-cited regulation is 21 CFR 211.160 (general requirements). The opening words of each observation are shown on this page.
Who inspected AARTI PHARMALABS LIMITED?
Jason R. Caballero is named on this Form 483, for the inspection of Feb 17 – Feb 20, 2020. Each investigator has a profile showing what they cite most.
When was AARTI PHARMALABS LIMITED inspected by FDA?
The inspection ran Feb 17 – Feb 20, 2020, and the Form 483 is dated February 20, 2020.
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.