Aarti Drugs Ltd.
Form 483 issued September 20, 2024 · Tarapur, India
- Inspection
- Sep 12 – Sep 20, 2024
- Investigators
- Rajiv R. Srivastava· Suzanne N. Vallez
- Observations
- 7
- Pages
- 12
- FEI number
- 3006418686
In short: On September 20, 2024, FDA issued a Form 483 with 7 observations to Aarti Drugs Ltd. in Tarapur, Maharashtra (FEI 3006418686) after an inspection that ran Sep 12 – Sep 20, 2024. The investigators were Rajiv R. Srivastava and Suzanne N. Vallez. Most observations concern quality system and laboratory controls.
At a glance
Quality system and laboratory controls account for 5 of 7 observations.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Written procedures is not established and followed for investigating critical deviations or the failure of a…
- 02
Test procedures is not scientifically sound and appropriate to ensure that raw materials, intermediates, and APIs…
- 03
You assign the storage conditions and retest or expiry dates of the APIs using test procedures…
- 04
Written procedures are not established for cleaning of equipment and its subsequent release for use in…
This inspection in context
Rajiv R. Srivastava
30 documents · 2018–2025
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in India.
The firmAarti Drugs 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 211.192
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Aarti Drugs Ltd.?
FDA listed 7 observations on this Form 483, mostly about quality system, laboratory controls and facilities & equipment. The opening words of each observation are shown on this page.
Who inspected Aarti Drugs Ltd.?
Rajiv R. Srivastava and Suzanne N. Vallez are named on this Form 483, for the inspection of Sep 12 – Sep 20, 2024. Each investigator has a profile showing what they cite most.
When was Aarti Drugs Ltd. inspected by FDA?
The inspection ran Sep 12 – Sep 20, 2024, and the Form 483 is dated September 20, 2024.
How do I get the full Form 483 for Aarti Drugs 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.