A.i.g. Technologies, Inc.
Form 483 issued November 17, 2015 · POMPANO BEACH, Florida
- Inspection
- Sep 29 – Nov 17, 2015
- Investigators
- Jennifer L. Huntington· Jennifer Lalama
- Observations
- 7
- Pages
- 4
- FEI number
- 3003511617
In short: On November 17, 2015, FDA issued a Form 483 with 7 observations to A.i.g. Technologies, Inc. in POMPANO BEACH, Florida (FEI 3003511617) after an inspection that ran Sep 29 – Nov 17, 2015. The investigators were Jennifer L. Huntington and Jennifer Lalama. Most observations concern laboratory controls and production.
At a glance
Laboratory controls and production account for 5 of 7 observations.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
The master production and control records are deficient in that they do not include a statement…
- 02
There are no written procedures for production and process controls designed to assure that the drug…
- 03
Representative samples are not taken of each shipment of each lot of components…
- 04
The suitability of all testing methods is not verified under…
This inspection in context
Jennifer L. Huntington
31 documents · 2015–2023
Cites 211.192 (production record review) 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 211.186
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 7 observations on this Form 483, mostly about laboratory controls, production and materials. The opening words of each observation are shown on this page.
Who inspected A.i.g. Technologies, Inc.?
Jennifer L. Huntington and Jennifer Lalama are named on this Form 483, for the inspection of Sep 29 – Nov 17, 2015. Each investigator has a profile showing what they cite most.
When was A.i.g. Technologies, Inc. inspected by FDA?
The inspection ran Sep 29 – Nov 17, 2015, and the Form 483 is dated November 17, 2015.
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.