Form 483 · FEI 3003871407
Form 483 issued July 9, 2015 · Richmond, Canada
- Inspection
- Jul 6 – Jul 9, 2015
- Investigator
- Lauren E. Skokan
- Observations
- 3
- Pages
- 4
- FEI number
- 3003871407
In short: On July 9, 2015, FDA issued a Form 483 with 3 observations to an FDA-inspected site in Richmond, Canada (FEI 3003871407) after an inspection that ran Jul 6 – Jul 9, 2015. The investigator was Lauren E. Skokan. Most observations concern production & process controls and design controls; the most-cited regulation is 21 CFR 820.70 (production and process controls).
At a glance
Production & process controls and design controls account for 2 of 3 observations.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Software used as part of production has not been validated for its intended use according…
- 0221 CFR 803
Procedures for receiving, reviewing, and evaluating complaints by a formally designated unit have…
- 03
Procedures for design change have…
This inspection in context
Questions about this 483
What did FDA find at an FDA-inspected site?
FDA listed 3 observations on this Form 483, mostly about production & process controls and design controls. The most-cited regulation is 21 CFR 820.70 (production and process controls). The opening words of each observation are shown on this page.
Who inspected an FDA-inspected site?
Lauren E. Skokan is named on this Form 483, for the inspection of Jul 6 – Jul 9, 2015. Each investigator has a profile showing what they cite most.
When was an FDA-inspected site inspected by FDA?
The inspection ran Jul 6 – Jul 9, 2015, and the Form 483 is dated July 9, 2015.
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.