Novartis Pharma Stein AG
Form 483 issued May 9, 2017 · Stein, Switzerland
- Inspection
- May 1 – May 9, 2017
- Investigator
- Don H. Bark
- Observations
- 8
- Pages
- 9
- FEI number
- 3002653483
In short: On May 9, 2017, FDA issued a Form 483 with 8 observations to Novartis Pharma Stein AG in Stein, Switzerland (FEI 3002653483) after an inspection that ran May 1 – May 9, 2017. The investigator was Don H. Bark. Most observations concern facilities & equipment and production; the most-cited regulation is 21 CFR 211.68 (automatic, mechanical, and electronic equipment).
At a glance
Observations span 4 systems, led by facilities & equipment.
What FDA observed
Preview: the opening words of each observation- 01
Testing and release of drug product for distribution do not include appropriate laboratory determination of satisfactory…
- 02
Investigations of a failure of a batch or any of its components to meet any of…
- 03
Backup data is not assured as secure from alteration, erasure or loss through keeping hard copy…
- 04
Routine calibration, inspection and checking of automatic and electronic equipment is not performed according to a…
This inspection in context
Don H. Bark
2 documents · 2015–2017
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in Switzerland.
The firmNovartis Pharma Stein AG history
All 4 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.165(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Novartis Pharma Stein AG?
FDA listed 8 observations on this Form 483, mostly about facilities & equipment, production and laboratory controls. The most-cited regulation is 21 CFR 211.68 (automatic, mechanical, and electronic equipment). The opening words of each observation are shown on this page.
Who inspected Novartis Pharma Stein AG?
Don H. Bark is named on this Form 483, for the inspection of May 1 – May 9, 2017. Each investigator has a profile showing what they cite most.
When was Novartis Pharma Stein AG inspected by FDA?
The inspection ran May 1 – May 9, 2017, and the Form 483 is dated May 9, 2017.
How do I get the full Form 483 for Novartis Pharma Stein AG?
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.