Intas Pharmaceuticals Ltd.
Form 483 issued December 7, 2023 · Ahmedabad, India
- Inspection
- Nov 30 – Dec 7, 2023
- Investigators
- Aditi S. Thakur· Hyung Lee· Jeanne Fringer
- Observations
- 7
- Pages
- 10
- FEI number
- 3007277149
In short: On December 7, 2023, FDA issued a Form 483 with 7 observations to Intas Pharmaceuticals Ltd. in Ahmedabad, Gujarat (FEI 3007277149) after an inspection that ran Nov 30 – Dec 7, 2023. The investigators were Aditi S. Thakur, Hyung Lee, Jeanne Fringer and Thuy T. Nguyen. Most observations concern production and laboratory controls; the most-cited regulation is 21 CFR 211.160 (general requirements).
At a glance
Observations span 4 systems, led by production.
Most cited: 21 CFR 211.192 (2×) · 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
Your firm failed to establish adequate written procedures for production and process control designed to assure…
- 02
Laboratory controls do not include the establishment of scientifically sound and appropriate test procedures designed to…
- 03
Written records of investigations into unexplained discrepancies, the failure of a batch or any of its…
- 04
Observation 4: scanned text, readable in the full document.
This inspection in context
Aditi S. Thakur
4 documents · 2018–2024
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in India.
The firmIntas Pharmaceuticals Ltd. history
All 3 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 Intas Pharmaceuticals Ltd.?
FDA listed 7 observations on this Form 483, mostly about production, 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 Intas Pharmaceuticals Ltd.?
Aditi S. Thakur, Hyung Lee, Jeanne Fringer and Thuy T. Nguyen are named on this Form 483, for the inspection of Nov 30 – Dec 7, 2023. Each investigator has a profile showing what they cite most.
When was Intas Pharmaceuticals Ltd. inspected by FDA?
The inspection ran Nov 30 – Dec 7, 2023, and the Form 483 is dated December 7, 2023.
How do I get the full Form 483 for Intas Pharmaceuticals 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.