Cadila Healthcare Limited Swaraj Majra, Juddi Kalan, Tehsil
Form 483 issued March 1, 2017 · Baddi, India
- Inspection
- Feb 21 – Mar 1, 2017
- Investigators
- Maria E. Estrella· Nicole E. Knowlton
- Observations
- 1
- Pages
- 3
- FEI number
- 3005430968
In short: On March 1, 2017, FDA issued a Form 483 with 1 observation to Cadila Healthcare Limited Swaraj Majra, Juddi Kalan, Tehsil in Baddi, India (FEI 3005430968) after an inspection that ran Feb 21 – Mar 1, 2017. The investigators were Maria E. Estrella and Nicole E. Knowlton. Most observations concern facilities & equipment; the most-cited regulation is 21 CFR 211.63 (equipment design, size, and location).
At a glance
1 of 1 observations on this 483 concern facilities & equipment.
Most cited: 21 CFR 211.63 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Equipment used in the manufacture, processing, packing or holding of drug products is not of appropriate…
This inspection in context
Maria E. Estrella
6 documents · 2017–2026
Cites 211.194 (laboratory records) more than any other section. Most of their documents are for sites in India.
The firmCadila Healthcare Limited Swaraj Majra, Juddi Kalan, Tehsil history
All 3 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.63
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Cadila Healthcare Limited Swaraj Majra, Juddi Kalan, Tehsil?
FDA listed 1 observation on this Form 483, mostly about facilities & equipment. The most-cited regulation is 21 CFR 211.63 (equipment design, size, and location). The opening words of each observation are shown on this page.
Who inspected Cadila Healthcare Limited Swaraj Majra, Juddi Kalan, Tehsil?
Maria E. Estrella and Nicole E. Knowlton are named on this Form 483, for the inspection of Feb 21 – Mar 1, 2017. Each investigator has a profile showing what they cite most.
When was Cadila Healthcare Limited Swaraj Majra, Juddi Kalan, Tehsil inspected by FDA?
The inspection ran Feb 21 – Mar 1, 2017, and the Form 483 is dated March 1, 2017.
How do I get the full Form 483 for Cadila Healthcare Limited Swaraj Majra, Juddi Kalan, Tehsil?
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.