Form 483 · FEI 3013133723
Form 483 issued November 4, 2019 · Sarasota, Florida
- Inspection
- Oct 28 – Nov 4, 2019
- Investigator
- Noreen Muniz
- Observations
- 8
- Pages
- 7
- FEI number
- 3013133723
In short: On November 4, 2019, FDA issued a Form 483 with 8 observations to an FDA-inspected site in Sarasota, Florida (FEI 3013133723) after an inspection that ran Oct 28 – Nov 4, 2019. The investigator was Noreen Muniz. Most observations concern production and laboratory controls; the most-cited regulation is 21 CFR 211.84 (testing and approval or rejection of components, drug product containers, and closures).
At a glance
Observations span 4 systems, led by production.
Most cited: 21 CFR 211.84(d)(2) (2×)
What FDA observed
Preview: the opening words of each observation- 01
The responsibilities and procedures applicable to the quality control unit are not in…
- 02
Control procedures are not established which of those manufacturing processes that may be responsible for causing…
- 03
The batch production and control records are deficient in that they do not include documentation of…
- 04
Laboratory controls do not include the establishment of scientifically sound and appropriate specifications, standards and test…
This inspection in context
Noreen Muniz
24 documents · 2008–2022
Cites 211.160 (general requirements) more than any other section. Most of their documents are for sites in Puerto Rico.
The firmSite history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.84(d)(2)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at an FDA-inspected site?
FDA listed 8 observations on this Form 483, mostly about production, laboratory controls and materials. The most-cited regulation is 21 CFR 211.84 (testing and approval or rejection of components, drug product containers, and closures). The opening words of each observation are shown on this page.
Who inspected an FDA-inspected site?
Noreen Muniz is named on this Form 483, for the inspection of Oct 28 – Nov 4, 2019. Each investigator has a profile showing what they cite most.
When was an FDA-inspected site inspected by FDA?
The inspection ran Oct 28 – Nov 4, 2019, and the Form 483 is dated November 4, 2019.
How do I get the full Form 483 for an FDA-inspected site?
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.