Sun Pharmaceutical Industries Ltd.
Form 483 issued August 31, 2018 · Halol, India
- Inspection
- Aug 27 – Aug 31, 2018
- Investigators
- Angela E. Glenn· Sarah Ibrahim
- Observations
- 2
- Pages
- 5
- FEI number
- 3002809586
In short: On August 31, 2018, FDA issued a Form 483 with 2 observations to Sun Pharmaceutical Industries Ltd. in Halol, Gujarat (FEI 3002809586) after an inspection that ran Aug 27 – Aug 31, 2018. The investigators were Angela E. Glenn and Sarah Ibrahim. Most observations concern laboratory controls and production; the most-cited regulation is 21 CFR 211.160 (general requirements).
At a glance
Laboratory controls and production account for 2 of 2 observations.
Most cited: 21 CFR 211.160 (1×) · 211.113 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Laboratory controls do not include the establishment of scientifically sound and appropriate test procedures designed to…
- 02
Procedures designed to prevent objectionable microorganisms in drug products not required to be…
This inspection in context
Angela E. Glenn
10 documents · 2016–2024
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 211.160
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Sun Pharmaceutical Industries Ltd.?
FDA listed 2 observations on this Form 483, mostly about laboratory controls and production. The most-cited regulation is 21 CFR 211.160 (general requirements). The opening words of each observation are shown on this page.
Who inspected Sun Pharmaceutical Industries Ltd.?
Angela E. Glenn and Sarah Ibrahim are named on this Form 483, for the inspection of Aug 27 – Aug 31, 2018. Each investigator has a profile showing what they cite most.
When was Sun Pharmaceutical Industries Ltd. inspected by FDA?
The inspection ran Aug 27 – Aug 31, 2018, and the Form 483 is dated August 31, 2018.
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.