Ajanta Pharma Limited
Form 483 issued June 22, 2019 · Bharuch, India
- Inspection
- Jun 17 – Jun 22, 2019
- Investigators
- Jose M. Cayuela· Kshiti Patkar
- Observations
- 3
- Pages
- 2
- FEI number
- 3012664809
In short: On June 22, 2019, FDA issued a Form 483 with 3 observations to Ajanta Pharma Limited in Bharuch, Gujarat (FEI 3012664809) after an inspection that ran Jun 17 – Jun 22, 2019. The investigators were Jose M. Cayuela and Kshiti Patkar. Most observations concern quality system and laboratory controls.
At a glance
2 of 3 observations on this 483 concern quality system.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
There is a failure to thoroughly review any unexplained discrepancy whether or not the batch…
- 02
The responsibilities and procedures applicable to the quality control unit…
- 03
Laboratory controls do not include a determination of conformance to appropriate…
This inspection in context
Jose M. Cayuela
23 documents · 2012–2025
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in India.
The firmAjanta Pharma Limited 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 Ajanta Pharma Limited?
FDA listed 3 observations on this Form 483, mostly about quality system and laboratory controls. The opening words of each observation are shown on this page.
Who inspected Ajanta Pharma Limited?
Jose M. Cayuela and Kshiti Patkar are named on this Form 483, for the inspection of Jun 17 – Jun 22, 2019. Each investigator has a profile showing what they cite most.
When was Ajanta Pharma Limited inspected by FDA?
The inspection ran Jun 17 – Jun 22, 2019, and the Form 483 is dated June 22, 2019.
How do I get the full Form 483 for Ajanta Pharma 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.