Cleveland Cord Blood Center
Form 483 issued September 15, 2023 · Warrensville Heights, Ohio
- Inspection
- Sep 11 – Sep 15, 2023
- Investigator
- Nancy L. Neiger
- Observations
- 4
- Pages
- 4
- FEI number
- 3006718574
In short: On September 15, 2023, FDA issued a Form 483 with 4 observations to Cleveland Cord Blood Center in Warrensville Heights, Ohio (FEI 3006718574) after an inspection that ran Sep 11 – Sep 15, 2023. The investigator was Nancy L. Neiger. Most observations concern facilities & equipment and biologics CGMP; the most-cited regulation is 21 CFR 211.42 (design and construction features).
At a glance
Facilities & equipment and biologics cgmp account for 3 of 4 observations.
What FDA observed
Preview: the opening words of each observation- 01
Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the equipment…
- 02
Aseptic processing areas are deficient regarding the system…
- 03
Records are not made concurrently with the performance of each step…
- 04
Written production and process control procedures are not followed in the execution of production…
This inspection in context
Nancy L. Neiger
3 documents · 2010–2023
Cites 211.42(c)(10)(iv) (design and construction features) more than any other section. Most of their documents are for sites in Ohio.
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 211.42(c)(10)(v)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Cleveland Cord Blood Center?
FDA listed 4 observations on this Form 483, mostly about facilities & equipment, biologics CGMP and production. 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?
Nancy L. Neiger is named on this Form 483, for the inspection of Sep 11 – Sep 15, 2023. Each investigator has a profile showing what they cite most.
When was Cleveland Cord Blood Center inspected by FDA?
The inspection ran Sep 11 – Sep 15, 2023, and the Form 483 is dated September 15, 2023.
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.