Rain Shadow Labs
Form 483 issued March 22, 2016 · Saint Helens, Oregon
- Inspection
- Mar 7 – Mar 22, 2016
- Investigator
- Nancy E. Byerly
- Observations
- 11
- Pages
- 6
- FEI number
- 3006078557
In short: On March 22, 2016, FDA issued a Form 483 with 11 observations to Rain Shadow Labs in Saint Helens, Oregon (FEI 3006078557) after an inspection that ran Mar 7 – Mar 22, 2016. The investigator was Nancy E. Byerly. Most observations concern facilities & equipment and laboratory controls.
At a glance
Observations span 4 systems, led by facilities & equipment.
What FDA observed
Preview: the opening words of each observation- 01
Each batch of drug product required to be free of objectionable microorganisms is not tested…
- 02
Laboratory controls do hot include the establishment of scientifically sound and appropriate specifications, standards, sampling plans…
- 03
There are no written procedures for production and process controls designed to assure that the drug…
- 04
The responsibilities and procedures applicable to the quality control unit…
This inspection in context
Nancy E. Byerly
7 documents · 2015–2017
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in Washington.
The firmRain Shadow Labs history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.165(b)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Rain Shadow Labs?
FDA listed 11 observations on this Form 483, mostly about facilities & equipment, laboratory controls and quality system. The opening words of each observation are shown on this page.
Who inspected Rain Shadow Labs?
Nancy E. Byerly is named on this Form 483, for the inspection of Mar 7 – Mar 22, 2016. Each investigator has a profile showing what they cite most.
When was Rain Shadow Labs inspected by FDA?
The inspection ran Mar 7 – Mar 22, 2016, and the Form 483 is dated March 22, 2016.
How do I get the full Form 483 for Rain Shadow Labs?
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.