Novacyl
Form 483 issued July 4, 2014 · Roussillon, France
- Inspection
- Jun 30 – Jul 4, 2014
- Investigator
- Linda Thai
- Observations
- 4
- Pages
- 2
- FEI number
- 3009804152
In short: On July 4, 2014, FDA issued a Form 483 with 4 observations to Novacyl in Roussillon, France (FEI 3009804152) after an inspection that ran Jun 30 – Jul 4, 2014. The investigator was Linda Thai. Most observations concern quality system and facilities & equipment.
At a glance
Observations span 2 systems, led by quality system.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
in our firm failed to conduct appropriate investigations to determine the root…
- 02
Your firm failed to conduct an investigation into the excursion of” in the, production of bulk…
- 03
Observation 3: scanned text, readable in the full document.
- 04
Observation 4: scanned text, readable in the full document.
This inspection in context
Linda Thai
18 documents · 2014–2025
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in California.
The firmNovacyl history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.192
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Novacyl?
FDA listed 4 observations on this Form 483, mostly about quality system and facilities & equipment. The opening words of each observation are shown on this page.
Who inspected Novacyl?
Linda Thai is named on this Form 483, for the inspection of Jun 30 – Jul 4, 2014. Each investigator has a profile showing what they cite most.
When was Novacyl inspected by FDA?
The inspection ran Jun 30 – Jul 4, 2014, and the Form 483 is dated July 4, 2014.
How do I get the full Form 483 for Novacyl?
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.