Puget SoWid Drug Corporation dba Key. Compounding Pharmacy
Form 483 issued March 8, 2017 · Federal Way, Washington
- Inspection
- Jan 26 – Mar 8, 2017
- Investigators
- Gary C. Pecic· Lisa T. Michel· Nancy E. Byerly
- Observations
- 10
- Pages
- 7
- FEI number
- 3006089725
In short: On March 8, 2017, FDA issued a Form 483 with 10 observations to Puget SoWid Drug Corporation dba Key. Compounding Pharmacy in Federal Way, Washington (FEI 3006089725) after an inspection that ran Jan 26 – Mar 8, 2017. The investigators were Gary C. Pecic, Lisa T. Michel and Nancy E. Byerly. Most observations concern production and facilities & equipment; the most-cited regulation is 21 CFR 211.113 (control of microbiological contamination).
At a glance
Production and facilities & equipment account for 9 of 10 observations.
Most cited: 21 CFR 211.113 (5×) · 211.42 (3×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Observation 1: scanned text, readable in the full document.
- 02
Aseptic practices are deficient regarding the system for cleaning and d~infecting the room…
- 03
Envin~nmental monitoring is not ade(pmtely perfonned…
- 04
There is a failure to thoroughly review any unexplained discrepancy whether or not the batch has…
This inspection in context
Gary C. Pecic
7 documents · 2015–2017
Cites 211.42 (design and construction features) 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 211.113
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 10 observations on this Form 483, mostly about production, facilities & equipment and quality system. The most-cited regulation is 21 CFR 211.113 (control of microbiological contamination). The opening words of each observation are shown on this page.
Who inspected Puget SoWid Drug Corporation dba Key. Compounding Pharmacy?
Gary C. Pecic, Lisa T. Michel and Nancy E. Byerly are named on this Form 483, for the inspection of Jan 26 – Mar 8, 2017. 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 Jan 26 – Mar 8, 2017, and the Form 483 is dated March 8, 2017.
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.