Ajanta Pharma Limited
Form 483 issued September 9, 2022 · Bharuch, India
- Inspection
- Sep 5 – Sep 9, 2022
- Investigator
- Joel D. Hustedt
- Observations
- 2
- Pages
- 1
- FEI number
- 3012664809
In short: On September 9, 2022, FDA issued a Form 483 with 2 observations to Ajanta Pharma Limited in Bharuch, Gujarat (FEI 3012664809) after an inspection that ran Sep 5 – Sep 9, 2022. The investigator was Joel D. Hustedt. Most observations concern quality system; the most-cited regulation is 21 CFR 211.192 (production record review).
At a glance
Observations span 1 system, led by quality system.
Most cited: 21 CFR 211.192 (1×) · 21 CFR 11 (1×)
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 has…
- 0221 CFR 11
Appropriate controls are not exercised over computers or related systems to assure that changes in master…
This inspection in context
Joel D. Hustedt
25 documents · 2009–2022
Cites 211.67 (equipment cleaning and maintenance) more than any other section. Most of their documents are for sites in China.
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 2 observations on this Form 483, mostly about quality system. The most-cited regulation is 21 CFR 211.192 (production record review). The opening words of each observation are shown on this page.
Who inspected Ajanta Pharma Limited?
Joel D. Hustedt is named on this Form 483, for the inspection of Sep 5 – Sep 9, 2022. Each investigator has a profile showing what they cite most.
When was Ajanta Pharma Limited inspected by FDA?
The inspection ran Sep 5 – Sep 9, 2022, and the Form 483 is dated September 9, 2022.
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.