Puget SoWid Drug Corporation dba Key. Compounding Pharmacy
Form 483 issued June 13, 2019 · Federal Way, Washington
- Inspection
- May 28 – Jun 13, 2019
- Investigators
- Andrew K. Haack· Peter S. Kessler
- Observations
- 1
- Pages
- 1
- FEI number
- 3006089725
In short: On June 13, 2019, FDA issued a Form 483 with 1 observation to Puget SoWid Drug Corporation dba Key. Compounding Pharmacy in Federal Way, Washington (FEI 3006089725) after an inspection that ran May 28 – Jun 13, 2019. The investigators were Andrew K. Haack and Peter S. Kessler. Most observations concern materials; the most-cited regulation is 21 CFR 211.84 (testing and approval or rejection of components, drug product containers, and closures).
At a glance
1 of 1 observations on this 483 concern materials.
Most cited: 21 CFR 211.84 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
You used a non-pharmaceutical grade component in the formulation…
This inspection in context
Andrew K. Haack
12 documents · 2017–2023
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in Washington.
The firmPuget SoWid Drug Corporation dba Key. Compounding Pharmacy history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.84
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Puget SoWid Drug Corporation dba Key. Compounding Pharmacy?
FDA listed 1 observation on this Form 483, mostly about materials. The most-cited regulation is 21 CFR 211.84 (testing and approval or rejection of components, drug product containers, and closures). The opening words of each observation are shown on this page.
Who inspected Puget SoWid Drug Corporation dba Key. Compounding Pharmacy?
Andrew K. Haack and Peter S. Kessler are named on this Form 483, for the inspection of May 28 – Jun 13, 2019. Each investigator has a profile showing what they cite most.
When was Puget SoWid Drug Corporation dba Key. Compounding Pharmacy inspected by FDA?
The inspection ran May 28 – Jun 13, 2019, and the Form 483 is dated June 13, 2019.
How do I get the full Form 483 for Puget SoWid Drug Corporation dba Key. Compounding Pharmacy?
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.