Sun Pharmaceuticals Industries Ltd.
Form 483 issued April 13, 2017 · Dadra, India
- Inspection
- Apr 6 – Apr 13, 2017
- Investigators
- Daniel J. Roberts· Sony Mathews
- Observations
- 11
- Pages
- 5
- FEI number
- 3004561553
In short: On April 13, 2017, FDA issued a Form 483 with 11 observations to Sun Pharmaceuticals Industries Ltd. in Dadra, India (FEI 3004561553) after an inspection that ran Apr 6 – Apr 13, 2017. The investigators were Daniel J. Roberts and Sony Mathews. Most observations concern quality system and laboratory controls.
At a glance
Observations span 3 systems, led by quality system.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Laboratory records do not include a complete record of all calculations and graphs performed in…
- 02
Batch production and control records for each batch of drug product produced do not include an…
- 03
The quality control unit lacks the authority to review production records to assure that…
- 04
Each lot of drug product is not withheld from use in quarantine before release from…
This inspection in context
Daniel J. Roberts
14 documents · 2011–2017
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in India.
The firmSun Pharmaceuticals Industries Ltd. history
All 5 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.194
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Sun Pharmaceuticals Industries Ltd.?
FDA listed 11 observations on this Form 483, mostly about quality system, laboratory controls and production. The opening words of each observation are shown on this page.
Who inspected Sun Pharmaceuticals Industries Ltd.?
Daniel J. Roberts and Sony Mathews are named on this Form 483, for the inspection of Apr 6 – Apr 13, 2017. Each investigator has a profile showing what they cite most.
When was Sun Pharmaceuticals Industries Ltd. inspected by FDA?
The inspection ran Apr 6 – Apr 13, 2017, and the Form 483 is dated April 13, 2017.
How do I get the full Form 483 for Sun Pharmaceuticals 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.