A.i.g. Technologies, Inc.
Form 483 issued July 1, 2011 · POMPANO BEACH, Florida
- Inspection
- Jun 27 – Jul 1, 2011
- Investigator
- Kimberly M. Hull
- Observations
- 9
- Pages
- 3
- FEI number
- 3003511617
In short: On July 1, 2011, FDA issued a Form 483 with 9 observations to A.i.g. Technologies, Inc. in POMPANO BEACH, Florida (FEI 3003511617) after an inspection that ran Jun 27 – Jul 1, 2011. The investigator was Kimberly M. Hull. Most observations concern quality system and production.
At a glance
Quality system and production account for 6 of 9 observations.
What FDA observed
Preview: the opening words of each observation- 01
There is no quality…
- 02
Employees are not given training in the particular operations they perform as part of their function…
- 03
Production personnel were not practicing good…
- 04
Records are not kept for the maintenance, cleaning, sanitizing…
This inspection in context
Kimberly M. Hull
1 document · 2011
Cites 211.100(a) (written procedures; deviations) 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 211.22(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 9 observations on this Form 483, mostly about quality system, production and facilities & equipment. The opening words of each observation are shown on this page.
Who inspected A.i.g. Technologies, Inc.?
Kimberly M. Hull is named on this Form 483, for the inspection of Jun 27 – Jul 1, 2011. Each investigator has a profile showing what they cite most.
When was A.i.g. Technologies, Inc. inspected by FDA?
The inspection ran Jun 27 – Jul 1, 2011, and the Form 483 is dated July 1, 2011.
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.