TEVA Animal Health
Form 483 issued April 21, 2009 · Saint Joseph, Missouri
- Inspection
- Feb 23 – Apr 21, 2009
- Investigators
- Danial S. Hutchison· Eric M. Mueller· Patrick L. Wisor
- Observations
- 17
- Pages
- 20
- FEI number
- 1000118231
In short: On April 21, 2009, FDA issued a Form 483 with 17 observations to TEVA Animal Health in Saint Joseph, Missouri (FEI 1000118231) after an inspection that ran Feb 23 – Apr 21, 2009. The investigators were Danial S. Hutchison, Eric M. Mueller, Patrick L. Wisor, Ralph H. Vocque and Warren J. Lopicka. Most observations concern laboratory controls and quality system; the most-cited regulation is 21 CFR 211.165 (testing and release for distribution).
At a glance
Laboratory controls and quality system account for 12 of 17 observations.
Most cited: 21 CFR 211.192 (2×) · 211.170(b) (2×)
What FDA observed
Preview: the opening words of each observation- 01
The responsibilities and procedures applicable to the quality control unit…
- 02
Drug products failing to meet established standards, specifications, and quality control…
- 03
Investigations of an unexplained discrepancy did not extend to other batches of the same drug product…
- 04
Observation 4: scanned text, readable in the full document.
This inspection in context
Danial S. Hutchison
2 documents · 2009–2013
Cites 211.100 (written procedures; deviations) more than any other section. Most of their documents are for sites in Michigan.
The firmTEVA Animal Health history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.192
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at TEVA Animal Health?
FDA listed 17 observations on this Form 483, mostly about laboratory controls, quality system and production. The most-cited regulation is 21 CFR 211.165 (testing and release for distribution). The opening words of each observation are shown on this page.
Who inspected TEVA Animal Health?
Danial S. Hutchison, Eric M. Mueller, Patrick L. Wisor, Ralph H. Vocque and Warren J. Lopicka are named on this Form 483, for the inspection of Feb 23 – Apr 21, 2009. Each investigator has a profile showing what they cite most.
When was TEVA Animal Health inspected by FDA?
The inspection ran Feb 23 – Apr 21, 2009, and the Form 483 is dated April 21, 2009.
How do I get the full Form 483 for TEVA Animal Health?
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.