Western Chemical Inc.
Form 483 issued March 22, 2019 · Ferndale, Washington
- Inspection
- Mar 18 – Mar 22, 2019
- Investigator
- Farhana Khan
- Observations
- 2
- Pages
- 4
- FEI number
- 3020195
In short: On March 22, 2019, FDA issued a Form 483 with 2 observations to Western Chemical Inc. in Ferndale, Washington (FEI 3020195) after an inspection that ran Mar 18 – Mar 22, 2019. The investigator was Farhana Khan. Most observations concern laboratory controls and quality system; the most-cited regulation is 21 CFR 211.166 (stability testing).
At a glance
Laboratory controls and quality system account for 2 of 2 observations.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Results of stability testing are not used in determining appropriate storage…
- 02
The responsibilities and procedures applicable to the quality control unit…
This inspection in context
Farhana Khan
7 documents · 2016–2021
Cites 211.160 (general requirements) more than any other section. Most of their documents are for sites in India.
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 211.166
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 laboratory controls and quality system. The most-cited regulation is 21 CFR 211.166 (stability testing). The opening words of each observation are shown on this page.
Who inspected Western Chemical Inc.?
Farhana Khan is named on this Form 483, for the inspection of Mar 18 – Mar 22, 2019. Each investigator has a profile showing what they cite most.
When was Western Chemical Inc. inspected by FDA?
The inspection ran Mar 18 – Mar 22, 2019, and the Form 483 is dated March 22, 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.