Sun Pharmaceutical Industries Ltd.
Form 483 issued June 11, 2019 · Halol, India
- Inspection
- Jun 3 – Jun 11, 2019
- Investigators
- Farhana Khan· Kejun Cheng· Monica C. Burgos Garcia
- Observations
- 4
- Pages
- 5
- FEI number
- 3002809586
In short: On June 11, 2019, FDA issued a Form 483 with 4 observations to Sun Pharmaceutical Industries Ltd. in Halol, Gujarat (FEI 3002809586) after an inspection that ran Jun 3 – Jun 11, 2019. The investigators were Farhana Khan, Kejun Cheng, Monica C. Burgos Garcia and Rebecca E. Dombrowski. Most observations concern production and laboratory controls.
At a glance
Observations span 4 systems, led by production.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not followed…
- 02
Established laboratory control mechanisms are not documented at the time of performance. The assurance of the…
- 03
Design plans that describe or reference the des ign and development activities and define responsibility for…
- 04
A process whose results cannot be fully verified by subsequent inspection and test has not been…
This inspection in context
Farhana Khan
7 documents · 2016–2021
Cites 211.160 (general requirements) more than any other section. Most of their documents are for sites in India.
The firmSun Pharmaceutical Industries Ltd. history
All 11 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.113
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Sun Pharmaceutical Industries Ltd.?
FDA listed 4 observations on this Form 483, mostly about production, laboratory controls and design controls. The opening words of each observation are shown on this page.
Who inspected Sun Pharmaceutical Industries Ltd.?
Farhana Khan, Kejun Cheng, Monica C. Burgos Garcia and Rebecca E. Dombrowski are named on this Form 483, for the inspection of Jun 3 – Jun 11, 2019. Each investigator has a profile showing what they cite most.
When was Sun Pharmaceutical Industries Ltd. inspected by FDA?
The inspection ran Jun 3 – Jun 11, 2019, and the Form 483 is dated June 11, 2019.
How do I get the full Form 483 for Sun Pharmaceutical Industries Ltd.?
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.