Donald J Garcia, Jr. M.D
Form 483 issued October 11, 2024 · Austin, Texas
- Inspection
- Oct 7 – Oct 11, 2024
- Investigator
- Iris C. Macinnes
- Observations
- 1
- Pages
- 3
- FEI number
- 3006683825
In short: On October 11, 2024, FDA issued a Form 483 with 1 observation to Donald J Garcia, Jr. M.D in Austin, Texas (FEI 3006683825) after an inspection that ran Oct 7 – Oct 11, 2024. The investigator was Iris C. Macinnes. Most observations concern clinical (BIMO); the most-cited regulation is 21 CFR 312.62 (investigator recordkeeping and record retention).
At a glance
1 of 1 observations on this 483 concern clinical (bimo).
Most cited: 21 CFR 312.62(b) (1×)
What FDA observed
Preview: the opening words of each observation- 01
Failure to prepare or maintain accurate case histories with respect to observations and data…
This inspection in context
Iris C. Macinnes
2 documents · 2012–2024
Cites 312.62(b) (investigator recordkeeping and record retention) more than any other section. Most of their documents are for sites in Texas.
The firmDonald J Garcia, Jr. M.D history
The site's inspection history, in date order.
Similar 483sOther sites cited under 312.62(b)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Donald J Garcia, Jr. M.D?
FDA listed 1 observation on this Form 483, mostly about clinical (BIMO). The most-cited regulation is 21 CFR 312.62 (investigator recordkeeping and record retention). The opening words of each observation are shown on this page.
Who inspected Donald J Garcia, Jr. M.D?
Iris C. Macinnes is named on this Form 483, for the inspection of Oct 7 – Oct 11, 2024. Each investigator has a profile showing what they cite most.
When was Donald J Garcia, Jr. M.D inspected by FDA?
The inspection ran Oct 7 – Oct 11, 2024, and the Form 483 is dated October 11, 2024.
How do I get the full Form 483 for Donald J Garcia, Jr. M.D?
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