Ricerca Biosciences, LLC
Form 483 issued August 13, 2021 · Painesville, Ohio
- Inspection
- Aug 2 – Aug 13, 2021
- Investigators
- Craig T. Rybus· Hugh M. McClure
- Observations
- 3
- Pages
- 4
- FEI number
- 1527393
In short: On August 13, 2021, FDA issued a Form 483 with 3 observations to Ricerca Biosciences, LLC in Painesville, Ohio (FEI 1527393) after an inspection that ran Aug 2 – Aug 13, 2021. The investigators were Craig T. Rybus and Hugh M. McClure. Most observations concern gLP.
At a glance
3 of 3 observations on this 483 concern glp.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
The quality assurance unit failed to determine whether any deviations from approved protocols or standard operating…
- 02
Not all equipment used for the generation, measurement, or assessment of data is adequately…
- 03
Conditions of storage failed to minimize deterioration of the documents in accordance with the requirements for…
This inspection in context
Craig T. Rybus
1 document · 2021
Cites 58.190 (storage and retrieval of records and data) more than any other section. Most of their documents are for sites in Ohio.
The firmRicerca Biosciences, LLC history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 58.35
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Ricerca Biosciences, LLC?
FDA listed 3 observations on this Form 483, mostly about gLP. The opening words of each observation are shown on this page.
Who inspected Ricerca Biosciences, LLC?
Craig T. Rybus and Hugh M. McClure are named on this Form 483, for the inspection of Aug 2 – Aug 13, 2021. Each investigator has a profile showing what they cite most.
When was Ricerca Biosciences, LLC inspected by FDA?
The inspection ran Aug 2 – Aug 13, 2021, and the Form 483 is dated August 13, 2021.
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.