A.i.g. Technologies, Inc.
Form 483 issued May 16, 2025 · POMPANO BEACH, Florida
- Inspection
- May 12 – May 16, 2025
- Investigators
- Afee Abeeb· Armen H. Youssoufian· Daniel L. Zheng
- Observations
- 5
- Pages
- 30
- FEI number
- 3003511617
In short: On May 16, 2025, FDA issued a Form 483 with 5 observations to A.i.g. Technologies, Inc. in POMPANO BEACH, Florida (FEI 3003511617) after an inspection that ran May 12 – May 16, 2025. The investigators were Afee Abeeb, Armen H. Youssoufian, Daniel L. Zheng and Jay-Ar C. Bendo. Most observations concern laboratory controls and materials; the most-cited regulation is 21 CFR 211.84 (testing and approval or rejection of components, drug product containers, and closures).
At a glance
3 of 5 observations on this 483 concern laboratory controls.
What FDA observed
Preview: the opening words of each observation- 01
Drug product component testing is deficient in that at least one specific test to verify the…
- 02
Representative samples are not taken of each shipment of each lot of components…
- 03
Laboratory records are deficient in that they do not include a complete record of all…
- 04
Laboratory controls do not include the establishment of scientifically sound and appropriate sampling plans designed to…
This inspection in context
Afee Abeeb
1 document · 2025
Cites 211.84(b) (testing and approval or rejection of components, drug product containers, and closures) more than any other section. Most of their documents are for sites in Florida.
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 211.84(d)(1)
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 5 observations on this Form 483, mostly about laboratory controls and materials. The most-cited regulation is 21 CFR 211.84 (testing and approval or rejection of components, drug product containers, and closures). The opening words of each observation are shown on this page.
Who inspected A.i.g. Technologies, Inc.?
Afee Abeeb, Armen H. Youssoufian, Daniel L. Zheng and Jay-Ar C. Bendo are named on this Form 483, for the inspection of May 12 – May 16, 2025. Each investigator has a profile showing what they cite most.
When was A.i.g. Technologies, Inc. inspected by FDA?
The inspection ran May 12 – May 16, 2025, and the Form 483 is dated May 16, 2025.
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.