Form 483 · FEI 3004058356
Form 483 issued August 19, 2016 · Pune, India
- Inspection
- Aug 16 – Aug 19, 2016
- Investigators
- Daniel J. Roberts· Patric C. Klotzbuecher
- Observations
- 1
- Pages
- 9
- FEI number
- 3004058356
In short: On August 19, 2016, FDA issued a Form 483 with 1 observation to an FDA-inspected site in Pune, India (FEI 3004058356) after an inspection that ran Aug 16 – Aug 19, 2016. The investigators were Daniel J. Roberts and Patric C. Klotzbuecher. Most observations concern quality system; the most-cited regulation is 21 CFR 211.22 (responsibilities of quality control unit).
At a glance
1 of 1 observations on this 483 concern quality system.
Most cited: 21 CFR 211.22 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Appropriate controls are not exercised to assure that changes to documents related to the manufacture of…
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 firmSite history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.22
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at an FDA-inspected site?
FDA listed 1 observation on this Form 483, mostly about quality system. The most-cited regulation is 21 CFR 211.22 (responsibilities of quality control unit). The opening words of each observation are shown on this page.
Who inspected an FDA-inspected site?
Daniel J. Roberts and Patric C. Klotzbuecher are named on this Form 483, for the inspection of Aug 16 – Aug 19, 2016. Each investigator has a profile showing what they cite most.
When was an FDA-inspected site inspected by FDA?
The inspection ran Aug 16 – Aug 19, 2016, and the Form 483 is dated August 19, 2016.
How do I get the full Form 483 for an FDA-inspected site?
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.