Form 483 · FEI 3011580268
Form 483 issued June 1, 2018 · Arecibo, Puerto Rico
- Inspection
- May 22 – Jun 1, 2018
- Investigator
- Arian Amirez
- Observations
- 1
- Pages
- 14
- FEI number
- 3011580268
In short: On June 1, 2018, FDA issued a Form 483 with 1 observation to an FDA-inspected site in Arecibo, Puerto Rico (FEI 3011580268) after an inspection that ran May 22 – Jun 1, 2018. The investigator was Arian Amirez. Most observations concern production; the most-cited regulation is 21 CFR 211.100 (written procedures; deviations).
At a glance
1 of 1 observations on this 483 concern production.
Most cited: 21 CFR 211.100(b) (1×)
What FDA observed
Preview: the opening words of each observation- 01
Written production and process control procedures are not followed in the execution of production and process…
This inspection in context
Arian Amirez
1 document · 2018
Cites 211.100(b) (written procedures; deviations) 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 211.100(b)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at an FDA-inspected site?
FDA listed 1 observation on this Form 483, mostly about production. The most-cited regulation is 21 CFR 211.100 (written procedures; deviations). The opening words of each observation are shown on this page.
Who inspected an FDA-inspected site?
Arian Amirez is named on this Form 483, for the inspection of May 22 – Jun 1, 2018. Each investigator has a profile showing what they cite most.
When was an FDA-inspected site inspected by FDA?
The inspection ran May 22 – Jun 1, 2018, and the Form 483 is dated June 1, 2018.
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.