Form 483 · FEI 1000150986
Form 483 issued February 28, 2014 · Sandpoint, Idaho
- Observations
- 2
- Pages
- 3
- FEI number
- 1000150986
In short: On February 28, 2014, FDA issued a Form 483 with 2 observations to an FDA-inspected site in Sandpoint, Idaho (FEI 1000150986). Most observations concern cAPA and production & process controls; the most-cited regulation is 21 CFR 820.100 (corrective and preventive action).
At a glance
CAPA and production & process controls account for 2 of 2 observations.
Most cited: 21 CFR 820.100(a) (1×) · 820.72(a) (1×)
What FDA observed
Preview: the opening words of each observation- 01
Procedures for corrective and preventive action have…
- 02
Procedures to ensure equipment is routinely calibrated have…
This inspection in context
Questions about this 483
What did FDA find at an FDA-inspected site?
FDA listed 2 observations on this Form 483, mostly about cAPA and production & process controls. The most-cited regulation is 21 CFR 820.100 (corrective and preventive action). The opening words of each observation are shown on this page.
When was an FDA-inspected site inspected by FDA?
This Form 483 is dated February 28, 2014.
How do I get the full Form 483 for an FDA-inspected site?
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.