Kleen Test Products Corporation
Form 483 issued June 14, 2006 · Port Washington, Wisconsin
- Inspection
- Jun 8 – Jun 14, 2006
- Observations
- 1
- Pages
- 1
- FEI number
- 3004586080
In short: On June 14, 2006, FDA issued a Form 483 with 1 observation to Kleen Test Products Corporation in Port Washington, Wisconsin (FEI 3004586080) after an inspection that ran Jun 8 – Jun 14, 2006. Most observations concern quality system; the most-cited regulation is 21 CFR 211.192 (production record review).
At a glance
1 of 1 observations on this 483 concern quality system.
Most cited: 21 CFR 211.192 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
There is a failure to thoroughly review any unexplained discrepancy whether or not the batch…
This inspection in context
Questions about this 483
What did FDA find at Kleen Test Products Corporation?
FDA listed 1 observation on this Form 483, mostly about quality system. The most-cited regulation is 21 CFR 211.192 (production record review). The opening words of each observation are shown on this page.
When was Kleen Test Products Corporation inspected by FDA?
The inspection ran Jun 8 – Jun 14, 2006, and the Form 483 is dated June 14, 2006.
How do I get the full Form 483 for Kleen Test Products Corporation?
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.