Solvay
Form 483 issued August 18, 2016 · Willow Island, West Virginia
- Inspection
- Aug 16 – Aug 18, 2016
- Investigator
- Zhongren Wu
- Observations
- 1
- Pages
- 1
- FEI number
- 1000305535
In short: On August 18, 2016, FDA issued a Form 483 with 1 observation to Solvay in Willow Island, West Virginia (FEI 1000305535) after an inspection that ran Aug 16 – Aug 18, 2016. The investigator was Zhongren Wu. Most observations concern facilities & equipment; the most-cited regulation is 21 CFR 211.68 (automatic, mechanical, and electronic equipment).
At a glance
1 of 1 observations on this 483 concern facilities & equipment.
Most cited: 21 CFR 211.68 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Critical data are being entered manually without an additional check on the accuracy of the entry…
This inspection in context
Zhongren Wu
8 documents · 2015–2021
Cites 211.67 (equipment cleaning and maintenance) more than any other section. Most of their documents are for sites in Maryland.
The firmSolvay 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 Solvay?
FDA listed 1 observation on this Form 483, mostly about facilities & equipment. 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 Solvay?
Zhongren Wu is named on this Form 483, for the inspection of Aug 16 – Aug 18, 2016. Each investigator has a profile showing what they cite most.
When was Solvay inspected by FDA?
The inspection ran Aug 16 – Aug 18, 2016, and the Form 483 is dated August 18, 2016.
How do I get the full Form 483 for Solvay?
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.