Donor Services Laboratories Inc Tampa
Form 483 issued September 12, 2025 · Tampa, Florida
- Inspection
- Sep 8 – Sep 12, 2025
- Investigators
- Lura D. Kelly· Nerming V. Briones· Steen N. Graham
- Observations
- 3
- Pages
- 4
- FEI number
- 3027286748
In short: On September 12, 2025, FDA issued a Form 483 with 3 observations to Donor Services Laboratories Inc Tampa in Tampa, Florida (FEI 3027286748) after an inspection that ran Sep 8 – Sep 12, 2025. The investigators were Lura D. Kelly, Nerming V. Briones and Steen N. Graham. Most observations concern hCT/P; the most-cited regulation is 21 CFR 1271.270 (records).
At a glance
3 of 3 observations on this 483 concern hct/p.
Most cited: 21 CFR 1271.270(a) (2×) · 1271.160(b)(6) (1×)
What FDA observed
Preview: the opening words of each observation- 01
Records were not maintained concurrently with the…
- 02
The quality program does not include the investigation and the documentation of HCT/P deviations relating…
- 03
Records did not identify the person performing the work and were not detailed as necessary to…
This inspection in context
Lura D. Kelly
1 document · 2025
Cites 1271.270(a) (records) more than any other section. Most of their documents are for sites in Florida.
The firmDonor Services Laboratories Inc Tampa history
The site's inspection history, in date order.
Similar 483sOther sites cited under 1271.270(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Donor Services Laboratories Inc Tampa?
FDA listed 3 observations on this Form 483, mostly about hCT/P. The most-cited regulation is 21 CFR 1271.270 (records). The opening words of each observation are shown on this page.
Who inspected Donor Services Laboratories Inc Tampa?
Lura D. Kelly, Nerming V. Briones and Steen N. Graham are named on this Form 483, for the inspection of Sep 8 – Sep 12, 2025. Each investigator has a profile showing what they cite most.
When was Donor Services Laboratories Inc Tampa inspected by FDA?
The inspection ran Sep 8 – Sep 12, 2025, and the Form 483 is dated September 12, 2025.
How do I get the full Form 483 for Donor Services Laboratories Inc Tampa?
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.