Western Chemical Inc.
FDA inspection history in Ferndale, Washington, 2019 to 2024
- 4
- Form 483s
Every document, by year
- Form 483
2019: two Form 483s; 2022: one Form 483; 2024: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2019Two Form 483s, at Ferndale, Washington.
- 2022–24Two Form 483s, at Ferndale, Washington.
- 2022The longest 483 on file: 4 observations over 5 pages at Ferndale, Washington.
Cited most
Across all Western Chemical observations on file
- 21 CFR 211.22Responsibilities of quality control unit2
- 21 CFR 211.100Written procedures; deviations1
- 21 CFR 211.160(b)General requirements1
- 21 CFR 211.166Stability testing1
- 21 CFR 211.188(b)(3)Batch production and control records1
The complete Western Chemical file.
All 4 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
The price of the documents, added to your cart together
Sites
Ferndale, Washington
Four Form 483s · 2019 to 2024 · 10 observations
Latest: Form 483, Oct 23, 2024 →
Documents
4 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2024-10-23 | 483 Form 483 | Ferndale, Washington | 2 | $99 |
| 2022-04-14 | 483 Form 483 | Ferndale, Washington | 4 | $99 |
| 2019-12-23 | 483 Form 483 | Ferndale, Washington | 2 | $99 |
| 2019-03-22 | 483 Form 483 | Ferndale, Washington | 2 | $99 |
Investigators on these documents
Bryan L. McGuckin (1)Farhana Khan (1)Grant M. Ruis (1)Roger F. Zabinski (1)
FEI number 3020195 · most recent document Oct 23, 2024
About Western Chemical Inc.
How many FDA Form 483s has Western Chemical Inc. received?
FDA Intel has 4 Form 483s on file for Western Chemical Inc.; the most recent is dated Oct 23, 2024.
When was Western Chemical Inc. last inspected by FDA?
The most recent FDA inspection document on file for Western Chemical Inc. is a Form 483 dated Oct 23, 2024, for the site in Ferndale, Washington.
What did FDA cite at Western Chemical Inc.?
The regulations cited most in the observations on file for Western Chemical Inc. are 21 CFR 211.22 (Responsibilities of quality control unit), 2 times; 21 CFR 211.100 (Written procedures; deviations), 1 time; 21 CFR 211.160(b) (General requirements), 1 time.