A.i.g. Technologies, Inc.
Form 483 issued September 25, 2019 · POMPANO BEACH, Florida
- Inspection
- Sep 17 – Sep 25, 2019
- Investigator
- Ariel Cruz Figueroa
- Observations
- 3
- Pages
- 4
- FEI number
- 3003511617
In short: On September 25, 2019, FDA issued a Form 483 with 3 observations to A.i.g. Technologies, Inc. in POMPANO BEACH, Florida (FEI 3003511617) after an inspection that ran Sep 17 – Sep 25, 2019. The investigator was Ariel Cruz Figueroa. Most observations concern laboratory controls and quality system.
At a glance
Laboratory controls and quality system account for 2 of 3 observations.
What FDA observed
Preview: the opening words of each observation- 01
Results of stability testing are not used…
- 02
Written records of investigations into unexplained discrepancies do not always include…
- 03
The master production and control records are deficient in that they do not include a complete…
This inspection in context
Ariel Cruz Figueroa
16 documents · 2015–2023
Cites 211.22 (responsibilities of quality control unit) more than any other section. Most of their documents are for sites in Puerto Rico.
The firmA.i.g. Technologies, Inc. history
All 6 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.166(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at A.i.g. Technologies, Inc.?
FDA listed 3 observations on this Form 483, mostly about laboratory controls, quality system and production. The opening words of each observation are shown on this page.
Who inspected A.i.g. Technologies, Inc.?
Ariel Cruz Figueroa is named on this Form 483, for the inspection of Sep 17 – Sep 25, 2019. Each investigator has a profile showing what they cite most.
When was A.i.g. Technologies, Inc. inspected by FDA?
The inspection ran Sep 17 – Sep 25, 2019, and the Form 483 is dated September 25, 2019.
How do I get the full Form 483 for A.i.g. Technologies, 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.