Ajanta Pharma Ltd.
Form 483 issued June 28, 2019 · Paithan, India
- Inspection
- Jun 24 – Jun 28, 2019
- Investigator
- Nicole E. Knowlton
- Observations
- 3
- Pages
- 2
- FEI number
- 3006785788
In short: On June 28, 2019, FDA issued a Form 483 with 3 observations to Ajanta Pharma Ltd. in Paithan, Maharashtra (FEI 3006785788) after an inspection that ran Jun 24 – Jun 28, 2019. The investigator was Nicole E. Knowlton. Most observations concern laboratory controls and facilities & equipment.
At a glance
2 of 3 observations on this 483 concern laboratory controls.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 03
Appropriate controls are not exercised over computers or related systems to assure that changes in master…
- 04
Laboratory controls do not include the establishment of scientifically sound and appropriate specifications designed to assure…
- 05
Laboratory records do not include complete records of the periodic…
This inspection in context
Nicole E. Knowlton
36 documents · 2013–2026
Cites 211.68 (automatic, mechanical, and electronic equipment) more than any other section. Most of their documents are for sites in Florida.
The firmAjanta Pharma Ltd. history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.68
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Ajanta Pharma Ltd.?
FDA listed 3 observations on this Form 483, mostly about laboratory controls and facilities & equipment. The opening words of each observation are shown on this page.
Who inspected Ajanta Pharma Ltd.?
Nicole E. Knowlton is named on this Form 483, for the inspection of Jun 24 – Jun 28, 2019. Each investigator has a profile showing what they cite most.
When was Ajanta Pharma Ltd. inspected by FDA?
The inspection ran Jun 24 – Jun 28, 2019, and the Form 483 is dated June 28, 2019.
How do I get the full Form 483 for Ajanta Pharma 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.