CiplaLtd
Form 483 issued May 3, 2024 · Kurkumbh, India
- Inspection
- Apr 29 – May 3, 2024
- Investigators
- Haitao Li· Santos E. Camara
- Observations
- 1
- Pages
- 1
- FEI number
- 3002806702
In short: On May 3, 2024, FDA issued a Form 483 with 1 observation to CiplaLtd in Kurkumbh, India (FEI 3002806702) after an inspection that ran Apr 29 – May 3, 2024. The investigators were Haitao Li and Santos E. Camara. Most observations concern quality system; the most-cited regulation is 21 CFR 211.22 (responsibilities of quality control unit).
At a glance
1 of 1 observations on this 483 concern quality system.
Most cited: 21 CFR 211.22 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
The responsibilities and procedures applicable to the quality control unit…
This inspection in context
Haitao Li
5 documents · 2019–2024
Cites 211.22 (responsibilities of quality control unit) more than any other section. Most of their documents are for sites in India.
The firmCiplaLtd history
All 4 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.22
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at CiplaLtd?
FDA listed 1 observation on this Form 483, mostly about quality system. The most-cited regulation is 21 CFR 211.22 (responsibilities of quality control unit). The opening words of each observation are shown on this page.
Who inspected CiplaLtd?
Haitao Li and Santos E. Camara are named on this Form 483, for the inspection of Apr 29 – May 3, 2024. Each investigator has a profile showing what they cite most.
When was CiplaLtd inspected by FDA?
The inspection ran Apr 29 – May 3, 2024, and the Form 483 is dated May 3, 2024.
How do I get the full Form 483 for CiplaLtd?
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.