WE Soda Wyoming LP
Form 483 issued July 15, 2021 · Green River, Wyoming
- Inspection
- Jul 12 – Jul 15, 2021
- Investigator
- Lisa Shin
- Observations
- 4
- Pages
- 5
- FEI number
- 1000117418
In short: On July 15, 2021, FDA issued a Form 483 with 4 observations to WE Soda Wyoming LP in Green River, Wyoming (FEI 1000117418) after an inspection that ran Jul 12 – Jul 15, 2021. The investigator was Lisa Shin. Most observations concern facilities & equipment and laboratory controls; the most-cited regulation is 21 CFR 211.68 (automatic, mechanical, and electronic equipment).
At a glance
Facilities & equipment and laboratory controls account for 3 of 4 observations.
Most cited: 21 CFR 211.68 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
There are no procedures for testing recovered materials to specifications suitable…
- 02
The controls over the computerized systems within the chemistry laboratory fail…
- 03
Investigations performed for Out-of-Specifications (OOS) are inadequate. 1. The root cause, corrective action and the outcome…
- 04
Written records do not contain accurate data and records do…
This inspection in context
Lisa Shin
13 documents · 2020–2023
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in California.
The firmWE Soda Wyoming LP history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.68
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at WE Soda Wyoming LP?
FDA listed 4 observations on this Form 483, mostly about facilities & equipment, laboratory controls and quality system. The most-cited regulation is 21 CFR 211.68 (automatic, mechanical, and electronic equipment). The opening words of each observation are shown on this page.
Who inspected WE Soda Wyoming LP?
Lisa Shin is named on this Form 483, for the inspection of Jul 12 – Jul 15, 2021. Each investigator has a profile showing what they cite most.
When was WE Soda Wyoming LP inspected by FDA?
The inspection ran Jul 12 – Jul 15, 2021, and the Form 483 is dated July 15, 2021.
How do I get the full Form 483 for WE Soda Wyoming LP?
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.