Teva Pharmaceutical Works Private Tancsics Mihaly ut 82
Form 483 issued January 29, 2016 · Godollo, Hungary
- Inspection
- Jan 21 – Jan 29, 2016
- Investigator
- Dustin A. Morgan
- Observations
- 1
- Pages
- 12
- FEI number
- 3002875215
In short: On January 29, 2016, FDA issued a Form 483 with 1 observation to Teva Pharmaceutical Works Private Tancsics Mihaly ut 82 in Godollo, Hungary (FEI 3002875215) after an inspection that ran Jan 21 – Jan 29, 2016. The investigator was Dustin A. Morgan. Most observations concern laboratory controls; the most-cited regulation is 21 CFR 211.194 (laboratory records).
At a glance
1 of 1 observations on this 483 concern laboratory controls.
Most cited: 21 CFR 211.194 (1×)
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 complete data derived from all tests, examinations and assay necessary to…
This inspection in context
Dustin A. Morgan
1 document · 2016
Cites 211.194 (laboratory records) more than any other section. Most of their documents are for sites in Hungary.
The firmTeva Pharmaceutical Works Private Tancsics Mihaly ut 82 history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.194
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Teva Pharmaceutical Works Private Tancsics Mihaly ut 82?
FDA listed 1 observation on this Form 483, mostly about laboratory controls. The most-cited regulation is 21 CFR 211.194 (laboratory records). The opening words of each observation are shown on this page.
Who inspected Teva Pharmaceutical Works Private Tancsics Mihaly ut 82?
Dustin A. Morgan is named on this Form 483, for the inspection of Jan 21 – Jan 29, 2016. Each investigator has a profile showing what they cite most.
When was Teva Pharmaceutical Works Private Tancsics Mihaly ut 82 inspected by FDA?
The inspection ran Jan 21 – Jan 29, 2016, and the Form 483 is dated January 29, 2016.
How do I get the full Form 483 for Teva Pharmaceutical Works Private Tancsics Mihaly ut 82?
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.