Durisan
Form 483 issued May 17, 2019 · Sarasota, Florida
- Inspection
- May 14 – May 17, 2019
- Investigator
- Libia M. Lugo
- Observations
- 9
- Pages
- 7
- FEI number
- 3014538924
In short: On May 17, 2019, FDA issued a Form 483 with 9 observations to Durisan in Sarasota, Florida (FEI 3014538924) after an inspection that ran May 14 – May 17, 2019. The investigator was Libia M. Lugo. 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 6 of 9 observations.
What FDA observed
Preview: the opening words of each observation- 01
There is no quality…
- 02
The batch production and control records are deficient in that they do not include documentation of…
- 03
Laboratory controls do not include the establishment of scientifically sound and appropriate specifications designed to assure…
- 04
Written procedures for sampling and testing plans are not followed…
This inspection in context
Libia M. Lugo
24 documents · 2013–2024
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in Puerto Rico.
The firmDurisan 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(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Durisan?
FDA listed 9 observations on this Form 483, mostly about laboratory controls, quality system and facilities & equipment. 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 Durisan?
Libia M. Lugo is named on this Form 483, for the inspection of May 14 – May 17, 2019. Each investigator has a profile showing what they cite most.
When was Durisan inspected by FDA?
The inspection ran May 14 – May 17, 2019, and the Form 483 is dated May 17, 2019.
How do I get the full Form 483 for Durisan?
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.