Form 483 · FEI 3010630287
Form 483 issued November 22, 2019 · Prigorje Brdovecko, Croatia
- Investigator
- Ram Sihag
- Observations
- 2
- Pages
- 2
- FEI number
- 3010630287
In short: On November 22, 2019, FDA issued a Form 483 with 2 observations to an FDA-inspected site in Prigorje Brdovecko, Croatia (FEI 3010630287). The investigator was Ram Sihag. Most observations concern laboratory controls; the most-cited regulation is 21 CFR 211.160 (general requirements).
At a glance
Observations span 1 system, led by laboratory controls.
Most cited: 21 CFR 211.160 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Your firm was unable to manufacture drug product purporting to be sterile because of a critical…
- 02
Written procedures are inadequate in the manufacture and testing of drug…
This inspection in context
Ram Sihag
2 documents · 2018–2019
Cites 211.160 (general requirements) more than any other section. Most of their documents are for sites in Austria.
The firmSite history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.160
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at an FDA-inspected site?
FDA listed 2 observations on this Form 483, mostly about laboratory controls. The most-cited regulation is 21 CFR 211.160 (general requirements). The opening words of each observation are shown on this page.
Who inspected an FDA-inspected site?
Ram Sihag is named on this Form 483. Each investigator has a profile showing what they cite most.
When was an FDA-inspected site inspected by FDA?
This Form 483 is dated November 22, 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.