Novacyl
Form 483 issued June 30, 2016 · Roussillon, France
- Inspection
- Jun 27 – Jun 30, 2016
- Observations
- 2
- Pages
- 1
- FEI number
- 3009804152
In short: On June 30, 2016, FDA issued a Form 483 with 2 observations to Novacyl in Roussillon, France (FEI 3009804152) after an inspection that ran Jun 27 – Jun 30, 2016. Most observations concern quality system and facilities & equipment; the most-cited regulation is 21 CFR 211.192 (production record review).
At a glance
Quality system and facilities & equipment account for 2 of 2 observations.
Most cited: 21 CFR 211.192 (1×) · 211.67 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
There is a failure to thoroughly review the failure of a batch or any of its…
- 02
Equipment is not maintained at appropriate intervals to prevent malfunctions or contamination that could alter the…
This inspection in context
Questions about this 483
What did FDA find at Novacyl?
FDA listed 2 observations on this Form 483, mostly about quality system and facilities & equipment. The most-cited regulation is 21 CFR 211.192 (production record review). The opening words of each observation are shown on this page.
When was Novacyl inspected by FDA?
The inspection ran Jun 27 – Jun 30, 2016, and the Form 483 is dated June 30, 2016.
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.