Cryobank America LLC
Form 483 issued January 13, 2025
- Inspection
- Jan 7 – Jan 13, 2025
- Investigator
- Ramon L. Gonzalez-Prieto
- Observations
- 2
- Pages
- 3
- FEI number
- 3013912801
In short: On January 13, 2025, FDA issued a Form 483 with 2 observations to Cryobank America LLC (FEI 3013912801) after an inspection that ran Jan 7 – Jan 13, 2025. The investigator was Ramon L. Gonzalez-Prieto. Most observations concern hCT/P; the most-cited regulation is 21 CFR 1271.55 (what records must accompany an HCT/P after the donor-eligibility determination is complete; and what records must I retain?).
At a glance
2 of 2 observations on this 483 concern hct/p.
Most cited: 21 CFR 1271.55 (1×) · 1271.47 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
The summary of records for HCT/Ps did not contain a statement that the communicable disease testing…
- 02
You did not establish and maintain procedures that address the retention of records related to testing…
This inspection in context
Ramon L. Gonzalez-Prieto
2 documents · 2025
Cites 1271.47 (what procedures must i establish and maintain?) more than any other section. Most of their documents are for sites in Texas.
The firmCryobank America LLC history
The site's inspection history, in date order.
Similar 483sOther sites cited under 1271.55
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Cryobank America LLC?
FDA listed 2 observations on this Form 483, mostly about hCT/P. The most-cited regulation is 21 CFR 1271.55 (what records must accompany an HCT/P after the donor-eligibility determination is complete; and what records must I retain?). The opening words of each observation are shown on this page.
Who inspected Cryobank America LLC?
Ramon L. Gonzalez-Prieto is named on this Form 483, for the inspection of Jan 7 – Jan 13, 2025. Each investigator has a profile showing what they cite most.
When was Cryobank America LLC inspected by FDA?
The inspection ran Jan 7 – Jan 13, 2025, and the Form 483 is dated January 13, 2025.
How do I get the full Form 483 for Cryobank America 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.