Cipla Limited
Form 483 issued April 13, 2018 · Pithampur, India
- Inspection
- Apr 2 – Apr 13, 2018
- Investigator
- Patric C. Klotzbuecher
- Observations
- 1
- Pages
- 5
- FEI number
- 3008581988
In short: On April 13, 2018, FDA issued a Form 483 with 1 observation to Cipla Limited in Pithampur, India (FEI 3008581988) after an inspection that ran Apr 2 – Apr 13, 2018. The investigator was Patric C. Klotzbuecher. Most observations concern laboratory controls; the most-cited regulation is 21 CFR 211.166 (stability testing).
At a glance
1 of 1 observations on this 483 concern laboratory controls.
Most cited: 21 CFR 211.166 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Testing programs are not adequately designed to assess the stability…
This inspection in context
Patric C. Klotzbuecher
13 documents · 2014–2019
Cites 211.160 (general requirements) more than any other section. Most of their documents are for sites in India.
The firmCipla Limited history
All 6 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.166
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Cipla Limited?
FDA listed 1 observation on this Form 483, mostly about laboratory controls. The most-cited regulation is 21 CFR 211.166 (stability testing). The opening words of each observation are shown on this page.
Who inspected Cipla Limited?
Patric C. Klotzbuecher is named on this Form 483, for the inspection of Apr 2 – Apr 13, 2018. Each investigator has a profile showing what they cite most.
When was Cipla Limited inspected by FDA?
The inspection ran Apr 2 – Apr 13, 2018, and the Form 483 is dated April 13, 2018.
How do I get the full Form 483 for Cipla 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.