Advanced Instrumentations
Form 483 issued February 26, 2024 · Miami, Florida
- Inspection
- Jan 30 – Feb 26, 2024
- Investigator
- Dianiris C. Ayala
- Observations
- 3
- Pages
- 8
- FEI number
- 3000957797
In short: On February 26, 2024, FDA issued a Form 483 with 3 observations to Advanced Instrumentations in Miami, Florida (FEI 3000957797) after an inspection that ran Jan 30 – Feb 26, 2024. The investigator was Dianiris C. Ayala. Most observations concern design controls and records & documents.
At a glance
Design controls and records & documents account for 2 of 3 observations.
What FDA observed
Preview: the opening words of each observation- 0121 CFR 820.30(j)21 CFR 820
The design history file does not demonstrate that the design was developed following the requirements…
- 02
Document control procedures have…
- 03
Procedures to ensure that all purchased or otherwise received product and services conform to specified requirements…
This inspection in context
Dianiris C. Ayala
8 documents · 2009–2024
Cites 820.100 (corrective and preventive action) more than any other section. Most of their documents are for sites in Florida.
The firmAdvanced Instrumentations history
The site's inspection history, in date order.
Similar 483sOther sites cited under 820.30(j)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Advanced Instrumentations?
FDA listed 3 observations on this Form 483, mostly about design controls, records & documents and production & process controls. The opening words of each observation are shown on this page.
Who inspected Advanced Instrumentations?
Dianiris C. Ayala is named on this Form 483, for the inspection of Jan 30 – Feb 26, 2024. Each investigator has a profile showing what they cite most.
When was Advanced Instrumentations inspected by FDA?
The inspection ran Jan 30 – Feb 26, 2024, and the Form 483 is dated February 26, 2024.
How do I get the full Form 483 for Advanced Instrumentations?
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.