Western Chemical Inc.
Form 483 issued April 14, 2022 · Ferndale, Washington
- Inspection
- Apr 11 – Apr 14, 2022
- Investigator
- Roger F. Zabinski
- Observations
- 4
- Pages
- 5
- FEI number
- 3020195
In short: On April 14, 2022, FDA issued a Form 483 with 4 observations to Western Chemical Inc. in Ferndale, Washington (FEI 3020195) after an inspection that ran Apr 11 – Apr 14, 2022. The investigator was Roger F. Zabinski. Most observations concern materials and quality system.
At a glance
Materials and quality system account for 3 of 4 observations.
What FDA observed
Preview: the opening words of each observation- 01
Investigations of an unexplained discrepancy and a failure of a batch or any of its components…
- 02
The batch production and control records are deficient in that they do not include specific identification…
- 03
There was a failure to handle and store components and drug product containers at all times…
- 04
Each component is not tested for conformity with all appropriate written specifications for…
This inspection in context
Roger F. Zabinski
36 documents · 2015–2026
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in California.
The firmWestern Chemical Inc. history
All 4 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.192
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Western Chemical Inc.?
FDA listed 4 observations on this Form 483, mostly about materials, quality system and production. The opening words of each observation are shown on this page.
Who inspected Western Chemical Inc.?
Roger F. Zabinski is named on this Form 483, for the inspection of Apr 11 – Apr 14, 2022. Each investigator has a profile showing what they cite most.
When was Western Chemical Inc. inspected by FDA?
The inspection ran Apr 11 – Apr 14, 2022, and the Form 483 is dated April 14, 2022.
How do I get the full Form 483 for Western Chemical Inc.?
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.