Methodist Hospital Blood Bank
Form 483 issued March 18, 2026
- Inspection
- Mar 5 – Mar 18, 2026
- Investigator
- Robert M. Tillman
- Observations
- 2
- Pages
- 5
- FEI number
- 1671793
In short: On March 18, 2026, FDA issued a Form 483 with 2 observations to Methodist Hospital Blood Bank (FEI 1671793) after an inspection that ran Mar 5 – Mar 18, 2026. The investigator was Robert M. Tillman. Most observations concern biologics CGMP; the most-cited regulation is 21 CFR 606.60 (equipment).
At a glance
2 of 2 observations on this 483 concern biologics cgmp.
Most cited: 21 CFR 606.60 (2×) · 606.160 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Equipment used in the processing of blood and blood components is not observed, standardized and calibrated…
- 02
Failure to maintain equipment used in the storage and distribution of…
This inspection in context
Questions about this 483
What did FDA find at Methodist Hospital Blood Bank?
FDA listed 2 observations on this Form 483, mostly about biologics CGMP. The most-cited regulation is 21 CFR 606.60 (equipment). The opening words of each observation are shown on this page.
Who inspected Methodist Hospital Blood Bank?
Robert M. Tillman is named on this Form 483, for the inspection of Mar 5 – Mar 18, 2026. Each investigator has a profile showing what they cite most.
When was Methodist Hospital Blood Bank inspected by FDA?
The inspection ran Mar 5 – Mar 18, 2026, and the Form 483 is dated March 18, 2026.
How do I get the full Form 483 for Methodist Hospital Blood Bank?
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.