CiplaLtd
Form 483 issued November 30, 2018 · Pune, India
- Inspection
- Nov 26 – Nov 30, 2018
- Investigator
- Rozelle G. Smith
- Observations
- 2
- Pages
- 3
- FEI number
- 3002806702
In short: On November 30, 2018, FDA issued a Form 483 with 2 observations to CiplaLtd in Pune, Maharashtra (FEI 3002806702) after an inspection that ran Nov 26 – Nov 30, 2018. The investigator was Rozelle G. Smith. Most observations concern facilities & equipment and production; the most-cited regulation is 21 CFR 211.67 (equipment cleaning and maintenance).
At a glance
Facilities & equipment and production account for 2 of 2 observations.
Most cited: 21 CFR 211.67 (1×) · 211.100 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Written procedures are not followed for the cleaning and maintenance of equipment, including utensils, used in…
- 02
Written production and process control procedures are not followed in the execution of production…
This inspection in context
Rozelle G. Smith
3 documents · 2017–2018
Cites 211.100 (written procedures; deviations) more than any other section. Most of their documents are for sites in Florida.
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 211.67
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at CiplaLtd?
FDA listed 2 observations on this Form 483, mostly about facilities & equipment and production. The most-cited regulation is 21 CFR 211.67 (equipment cleaning and maintenance). The opening words of each observation are shown on this page.
Who inspected CiplaLtd?
Rozelle G. Smith is named on this Form 483, for the inspection of Nov 26 – Nov 30, 2018. Each investigator has a profile showing what they cite most.
When was CiplaLtd inspected by FDA?
The inspection ran Nov 26 – Nov 30, 2018, and the Form 483 is dated November 30, 2018.
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.