Ricerca Biosciences, LLC
Form 483 issued September 23, 2016 · Painesville, Ohio
- Inspection
- Sep 19 – Sep 23, 2016
- Investigator
- Richard W. Berning
- Observations
- 1
- Pages
- 2
- FEI number
- 1527393
In short: On September 23, 2016, FDA issued a Form 483 with 1 observation to Ricerca Biosciences, LLC in Painesville, Ohio (FEI 1527393) after an inspection that ran Sep 19 – Sep 23, 2016. The investigator was Richard W. Berning. Most observations concern gLP; the most-cited regulation is 21 CFR 58.120 (protocol).
At a glance
1 of 1 observations on this 483 concern glp.
Most cited: 21 CFR 58.120 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 0121 CFR 58.120
Not all protocols contained the type and frequency of tests, analyses, and measurements…
This inspection in context
Richard W. Berning
3 documents · 2016–2026
Cites 312.50 (general responsibilities of sponsors) more than any other section. Most of their documents are for sites in China.
The firmRicerca Biosciences, LLC history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
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Questions about this 483
What did FDA find at Ricerca Biosciences, LLC?
FDA listed 1 observation on this Form 483, mostly about gLP. The most-cited regulation is 21 CFR 58.120 (protocol). The opening words of each observation are shown on this page.
Who inspected Ricerca Biosciences, LLC?
Richard W. Berning is named on this Form 483, for the inspection of Sep 19 – Sep 23, 2016. Each investigator has a profile showing what they cite most.
When was Ricerca Biosciences, LLC inspected by FDA?
The inspection ran Sep 19 – Sep 23, 2016, and the Form 483 is dated September 23, 2016.
How do I get the full Form 483 for Ricerca Biosciences, LLC?
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.