Flamma SpA
Form 483 issued September 21, 2018 · Bulciago, Italy
- Inspection
- Sep 17 – Sep 21, 2018
- Investigator
- Darran S. Brown
- Observations
- 6
- Pages
- 4
- FEI number
- 3002806311
In short: On September 21, 2018, FDA issued a Form 483 with 6 observations to Flamma SpA in Bulciago, LC (FEI 3002806311) after an inspection that ran Sep 17 – Sep 21, 2018. The investigator was Darran S. Brown. 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 4 of 6 observations.
Most cited: 21 CFR 211.192 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Warehousing operations are not consistent with…
- 02
Your firm’s investigation failed to…
- 03
CAPAs are not taken…
- 04
Your firm does not adequately protect API…
This inspection in context
Darran S. Brown
1 document · 2018
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in Italy.
The firmFlamma SpA history
The site's inspection history, in date order.
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 Flamma SpA?
FDA listed 6 observations on this Form 483, mostly about quality system, facilities & equipment and laboratory controls. The most-cited regulation is 21 CFR 211.192 (production record review). The opening words of each observation are shown on this page.
Who inspected Flamma SpA?
Darran S. Brown is named on this Form 483, for the inspection of Sep 17 – Sep 21, 2018. Each investigator has a profile showing what they cite most.
When was Flamma SpA inspected by FDA?
The inspection ran Sep 17 – Sep 21, 2018, and the Form 483 is dated September 21, 2018.
How do I get the full Form 483 for Flamma SpA?
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.