Advanced Ambulatory, Inc
Form 483 issued July 31, 2024 · Houston, Texas
- Inspection
- Jul 16 – Jul 31, 2024
- Investigator
- Ellen J. Tave
- Observations
- 1
- Pages
- 9
- FEI number
- 3015004731
In short: On July 31, 2024, FDA issued a Form 483 with 1 observation to Advanced Ambulatory, Inc in Houston, Texas (FEI 3015004731) after an inspection that ran Jul 16 – Jul 31, 2024. The investigator was Ellen J. Tave. Most observations concern cAPA; the most-cited regulation is 21 CFR 820.198 (complaint files).
At a glance
1 of 1 observations on this 483 concern capa.
Most cited: 21 CFR 820.198(a) (1×)
What FDA observed
Preview: the opening words of each observation- 01
Procedures for receiving, reviewing, and evaluating complaints by a formally designated unit have…
This inspection in context
Ellen J. Tave
8 documents · 2015–2024
Cites 820.30(g) (design controls) more than any other section. Most of their documents are for sites in Texas.
The firmAdvanced Ambulatory, Inc history
The site's inspection history, in date order.
Similar 483sOther sites cited under 820.198(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Advanced Ambulatory, Inc?
FDA listed 1 observation on this Form 483, mostly about cAPA. The most-cited regulation is 21 CFR 820.198 (complaint files). The opening words of each observation are shown on this page.
Who inspected Advanced Ambulatory, Inc?
Ellen J. Tave is named on this Form 483, for the inspection of Jul 16 – Jul 31, 2024. Each investigator has a profile showing what they cite most.
When was Advanced Ambulatory, Inc inspected by FDA?
The inspection ran Jul 16 – Jul 31, 2024, and the Form 483 is dated July 31, 2024.
How do I get the full Form 483 for Advanced Ambulatory, 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.