Cleveland Cord Blood Center
Form 483 issued January 17, 2020 · Warrensville Heights, Ohio
- Inspection
- Jan 13 – Jan 17, 2020
- Investigators
- Gene D. Arcy· Nimmy Mathews
- Observations
- 9
- Pages
- 7
- FEI number
- 3006718574
In short: On January 17, 2020, FDA issued a Form 483 with 9 observations to Cleveland Cord Blood Center in Warrensville Heights, Ohio (FEI 3006718574) after an inspection that ran Jan 13 – Jan 17, 2020. The investigators were Gene D. Arcy and Nimmy Mathews. Most observations concern facilities & equipment and production; the most-cited regulation is 21 CFR 211.42 (design and construction features).
At a glance
Observations span 4 systems, led by facilities & equipment.
What FDA observed
Preview: the opening words of each observation- 01
There are no written procedures for production and process controls designed to assure that the drug…
- 02
There is a failure to thoroughly review any unexplained discrepancy whether or not the batch…
- 03
Procedures designed to prevent objectionable microorganisms in drug products not required to be…
- 04
Laboratory controls do not include the establishment of scientifically sound and appropriate test procedures designed to…
This inspection in context
Gene D. Arcy
16 documents · 2003–2025
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in California.
The firmCleveland Cord Blood Center history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.100(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Cleveland Cord Blood Center?
FDA listed 9 observations on this Form 483, mostly about facilities & equipment, production and laboratory controls. The most-cited regulation is 21 CFR 211.42 (design and construction features). The opening words of each observation are shown on this page.
Who inspected Cleveland Cord Blood Center?
Gene D. Arcy and Nimmy Mathews are named on this Form 483, for the inspection of Jan 13 – Jan 17, 2020. Each investigator has a profile showing what they cite most.
When was Cleveland Cord Blood Center inspected by FDA?
The inspection ran Jan 13 – Jan 17, 2020, and the Form 483 is dated January 17, 2020.
How do I get the full Form 483 for Cleveland Cord Blood Center?
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.