Western Chemical Inc.
Form 483 issued December 23, 2019 · Ferndale, Washington
- Inspection
- Dec 18 – Dec 23, 2019
- Investigator
- Bryan L. McGuckin
- Observations
- 2
- Pages
- 3
- FEI number
- 3020195
In short: On December 23, 2019, FDA issued a Form 483 with 2 observations to Western Chemical Inc. in Ferndale, Washington (FEI 3020195) after an inspection that ran Dec 18 – Dec 23, 2019. The investigator was Bryan L. McGuckin. Most observations concern quality system and laboratory controls; the most-cited regulation is 21 CFR 211.22 (responsibilities of quality control unit).
At a glance
Quality system and laboratory controls account for 2 of 2 observations.
Most cited: 21 CFR 211.22(d) (1×) · 211.160(b) (1×)
What FDA observed
Preview: the opening words of each observation- 01
The responsibilities and procedures applicable to the quality control unit…
- 02
Laboratory controls do not include the establishment of scientifically sound and appropriate standards designed to assure…
This inspection in context
Bryan L. McGuckin
30 documents · 2017–2026
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in Illinois.
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 211.22(d)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Western Chemical Inc.?
FDA listed 2 observations on this Form 483, mostly about quality system and laboratory controls. The most-cited regulation is 21 CFR 211.22 (responsibilities of quality control unit). The opening words of each observation are shown on this page.
Who inspected Western Chemical Inc.?
Bryan L. McGuckin is named on this Form 483, for the inspection of Dec 18 – Dec 23, 2019. Each investigator has a profile showing what they cite most.
When was Western Chemical Inc. inspected by FDA?
The inspection ran Dec 18 – Dec 23, 2019, and the Form 483 is dated December 23, 2019.
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.