Sun Pharmaceutical Industries, Inc
Form 483 issued March 9, 2018 · Cranbury, New Jersey
- Inspection
- Feb 13 – Mar 9, 2018
- Investigators
- Adetutu Gidado· Nancy F. Scheraga
- Observations
- 8
- Pages
- 9
- FEI number
- 3005551493
In short: On March 9, 2018, FDA issued a Form 483 with 8 observations to Sun Pharmaceutical Industries, Inc in Cranbury, New Jersey (FEI 3005551493) after an inspection that ran Feb 13 – Mar 9, 2018. The investigators were Adetutu Gidado and Nancy F. Scheraga. Most observations concern facilities & equipment and quality system; the most-cited regulation is 21 CFR 211.192 (production record review).
At a glance
Facilities & equipment and quality system account for 6 of 8 observations.
Most cited: 21 CFR 211.192 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Inspection of the packaging facilities is not done after use to assure that materials not suitable…
- 02
Routine checking of automatic and electronic equipment is not performed according to a written program designed…
- 03
The responsibilities and procedures applicable to the quality control unit…
- 04
There is a failure to thoroughly review any unexplained discrepancy whether or not the batch…
This inspection in context
Adetutu Gidado
16 documents · 2016–2025
Cites 211.68 (automatic, mechanical, and electronic equipment) more than any other section. Most of their documents are for sites in New Jersey.
The firmSun Pharmaceutical Industries, Inc history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.192
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Sun Pharmaceutical Industries, Inc?
FDA listed 8 observations on this Form 483, mostly about facilities & equipment, quality system and packaging & labeling. The most-cited regulation is 21 CFR 211.192 (production record review). The opening words of each observation are shown on this page.
Who inspected Sun Pharmaceutical Industries, Inc?
Adetutu Gidado and Nancy F. Scheraga are named on this Form 483, for the inspection of Feb 13 – Mar 9, 2018. Each investigator has a profile showing what they cite most.
When was Sun Pharmaceutical Industries, Inc inspected by FDA?
The inspection ran Feb 13 – Mar 9, 2018, and the Form 483 is dated March 9, 2018.
How do I get the full Form 483 for Sun Pharmaceutical Industries, Inc?
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.