Natura Bisse International SA
Form 483 issued September 16, 2022 · Barcelona, Spain
- Inspection
- Sep 12 – Sep 16, 2022
- Investigator
- Saundrea A. Munroe
- Observations
- 2
- Pages
- 2
- FEI number
- 3008301076
In short: On September 16, 2022, FDA issued a Form 483 with 2 observations to Natura Bisse International SA in Barcelona, Spain (FEI 3008301076) after an inspection that ran Sep 12 – Sep 16, 2022. The investigator was Saundrea A. Munroe. Most observations concern laboratory controls and facilities & equipment; the most-cited regulation is 21 CFR 211.160 (general requirements).
At a glance
Laboratory controls and facilities & equipment account for 2 of 2 observations.
Most cited: 21 CFR 211.160(b) (1×) · 211.63 (1×)
What FDA observed
Preview: the opening words of each observation- 01
Laboratory controls do not include the establishment of scientifically sound and appropriate specifications designed to assure…
- 02
Equipment used in the manufacture, processing, packing or holding of drug products is not of appropriate…
This inspection in context
Saundrea A. Munroe
30 documents · 2018–2026
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in Florida.
The firmNatura Bisse International SA history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.160(b)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Natura Bisse International SA?
FDA listed 2 observations on this Form 483, mostly about laboratory controls and facilities & equipment. The most-cited regulation is 21 CFR 211.160 (general requirements). The opening words of each observation are shown on this page.
Who inspected Natura Bisse International SA?
Saundrea A. Munroe is named on this Form 483, for the inspection of Sep 12 – Sep 16, 2022. Each investigator has a profile showing what they cite most.
When was Natura Bisse International SA inspected by FDA?
The inspection ran Sep 12 – Sep 16, 2022, and the Form 483 is dated September 16, 2022.
How do I get the full Form 483 for Natura Bisse International SA?
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.