Cohance Lifesciences Limited
Form 483 issued August 20, 2019 · Medchal-Malkajgiri, India
- Inspection
- Aug 12 – Aug 20, 2019
- Investigator
- Nicole E. Knowlton
- Observations
- 3
- Pages
- 3
- FEI number
- 3008768274
In short: On August 20, 2019, FDA issued a Form 483 with 3 observations to Cohance Lifesciences Limited in Medchal-Malkajgiri, Telangana (FEI 3008768274) after an inspection that ran Aug 12 – Aug 20, 2019. The investigator was Nicole E. Knowlton. Most observations concern laboratory controls and facilities & equipment.
At a glance
Laboratory controls and facilities & equipment account for 2 of 3 observations.
What FDA observed
Preview: the opening words of each observation- 01
Laboratory controls do not include the establishment of scientifically sound and appropriate sampling plans designed to…
- 02
Equipment used in the manufacture, processing, packing or holding of drug products is not of appropriate…
- 03
The quality control unit lacks responsibility to approve and reject all procedures or specifications impacting on…
This inspection in context
Nicole E. Knowlton
36 documents · 2013–2026
Cites 211.68 (automatic, mechanical, and electronic equipment) more than any other section. Most of their documents are for sites in Florida.
The firmCohance Lifesciences Limited history
All 3 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.160(b)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Cohance Lifesciences Limited?
FDA listed 3 observations on this Form 483, mostly about laboratory controls, facilities & equipment and quality system. The opening words of each observation are shown on this page.
Who inspected Cohance Lifesciences Limited?
Nicole E. Knowlton is named on this Form 483, for the inspection of Aug 12 – Aug 20, 2019. Each investigator has a profile showing what they cite most.
When was Cohance Lifesciences Limited inspected by FDA?
The inspection ran Aug 12 – Aug 20, 2019, and the Form 483 is dated August 20, 2019.
How do I get the full Form 483 for Cohance Lifesciences 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.