Tropichem Research Labs, LLC dba Vetio
Form 483 issued December 14, 2018 · Jupiter, Florida
- Inspection
- Dec 10 – Dec 14, 2018
- Investigator
- Jennifer L. Huntington
- Observations
- 7
- Pages
- 5
- FEI number
- 1000113165
In short: On December 14, 2018, FDA issued a Form 483 with 7 observations to Tropichem Research Labs, LLC dba Vetio in Jupiter, Florida (FEI 1000113165) after an inspection that ran Dec 10 – Dec 14, 2018. The investigator was Jennifer L. Huntington. Most observations concern laboratory controls and facilities & equipment.
At a glance
Observations span 4 systems, led by laboratory controls.
What FDA observed
Preview: the opening words of each observation- 01
There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch…
- 02
Determinations of conformance to appropriate written specifications for acceptance are not…
- 03
Testing and release of drug product for distribution do not include appropriate laboratory determination of satisfactory…
- 04
Appropriate controls are not exercised over computers or related systems to assure that changes in master…
This inspection in context
Jennifer L. Huntington
31 documents · 2015–2023
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in Florida.
The firmTropichem Research Labs, LLC dba Vetio 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 Tropichem Research Labs, LLC dba Vetio?
FDA listed 7 observations on this Form 483, mostly about laboratory controls, facilities & equipment and quality system. The opening words of each observation are shown on this page.
Who inspected Tropichem Research Labs, LLC dba Vetio?
Jennifer L. Huntington is named on this Form 483, for the inspection of Dec 10 – Dec 14, 2018. Each investigator has a profile showing what they cite most.
When was Tropichem Research Labs, LLC dba Vetio inspected by FDA?
The inspection ran Dec 10 – Dec 14, 2018, and the Form 483 is dated December 14, 2018.
How do I get the full Form 483 for Tropichem Research Labs, LLC dba Vetio?
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.