Sun Pharmaceutical Industries Ltd.
Form 483 issued November 8, 2019 · Bharuch, India
- Inspection
- Nov 4 – Nov 8, 2019
- Investigator
- Cheryl Clausen
- Observations
- 3
- Pages
- 3
- FEI number
- 3003952717
In short: On November 8, 2019, FDA issued a Form 483 with 3 observations to Sun Pharmaceutical Industries Ltd. in Bharuch, Gujarat (FEI 3003952717) after an inspection that ran Nov 4 – Nov 8, 2019. The investigator was Cheryl Clausen. Most observations concern quality system and laboratory controls.
At a glance
2 of 3 observations on this 483 concern quality system.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Your written procedures for testing are not always scientifically sound and/or written with sufficient details to…
- 02
You do not always adequately investigate and…
- 03
Quality related complaint investigations are…
This inspection in context
Cheryl Clausen
18 documents · 2016–2020
Cites 211.22 (responsibilities of quality control unit) more than any other section. Most of their documents are for sites in India.
The firmSun Pharmaceutical Industries Ltd. history
The site's inspection history, in date order.
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 3 observations on this Form 483, mostly about quality system and laboratory controls. The opening words of each observation are shown on this page.
Who inspected Sun Pharmaceutical Industries Ltd.?
Cheryl Clausen is named on this Form 483, for the inspection of Nov 4 – Nov 8, 2019. Each investigator has a profile showing what they cite most.
When was Sun Pharmaceutical Industries Ltd. inspected by FDA?
The inspection ran Nov 4 – Nov 8, 2019, and the Form 483 is dated November 8, 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.