Innovative Transfusion Medicine, Inc.
Form 483 issued October 7, 2024 · Florida
- Inspection
- Sep 30 – Oct 7, 2024
- Investigators
- Nerming V. Briones· Sergio E. Delgado
- Observations
- 4
- Pages
- 5
- FEI number
- 3000207042
In short: On October 7, 2024, FDA issued a Form 483 with 4 observations to Innovative Transfusion Medicine, Inc. in Florida (FEI 3000207042) after an inspection that ran Sep 30 – Oct 7, 2024. The investigators were Nerming V. Briones and Sergio E. Delgado. Most observations concern biologics CGMP; the most-cited regulation is 21 CFR 610.47 (hepatitis C virus (HCV) “lookback” requirements).
At a glance
4 of 4 observations on this 483 concern biologics cgmp.
Most cited: 21 CFR 610.47(a)(1) (2×)
What FDA observed
Preview: the opening words of each observation- 0121 CFR 610.47(a)(1)
Failure to review all records required under the regulations to identify previously donated blood and blood…
- 0221 CFR 610.47(a)(1)
Failure to review all records required under the regulations to identify previously donated blood and blood…
- 03
Written standard operating procedures including all steps to be followed in the collection, processing and storage…
- 04
Failure to maintain general…
This inspection in context
Nerming V. Briones
2 documents · 2024–2025
Cites 1271.270(a) (records) more than any other section. Most of their documents are for sites in Florida.
The firmInnovative Transfusion Medicine, Inc. history
The site's inspection history, in date order.
Similar 483sOther sites cited under 606.100(b)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Innovative Transfusion Medicine, Inc.?
FDA listed 4 observations on this Form 483, mostly about biologics CGMP. The most-cited regulation is 21 CFR 610.47 (hepatitis C virus (HCV) “lookback” requirements). The opening words of each observation are shown on this page.
Who inspected Innovative Transfusion Medicine, Inc.?
Nerming V. Briones and Sergio E. Delgado are named on this Form 483, for the inspection of Sep 30 – Oct 7, 2024. Each investigator has a profile showing what they cite most.
When was Innovative Transfusion Medicine, Inc. inspected by FDA?
The inspection ran Sep 30 – Oct 7, 2024, and the Form 483 is dated October 7, 2024.
How do I get the full Form 483 for Innovative Transfusion Medicine, Inc.?
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.