Ballard Plaza Pharmacy I, Inc.
Form 483 issued June 10, 2016 · Seattle, Washington
- Inspection
- Apr 25 – May 17, 2016
- Investigators
- Christopher R. Czajka· Gary C. Pecic· Gerard P. De Leon
- Observations
- 6
- Pages
- 10
- FEI number
- 3006317860
In short: On June 10, 2016, FDA issued a Form 483 with 6 observations to Ballard Plaza Pharmacy I, Inc. in Seattle, Washington (FEI 3006317860) after an inspection that ran Apr 25 – May 17, 2016. The investigators were Christopher R. Czajka, Gary C. Pecic, Gerard P. De Leon and Lisa T. Michel. Most observations concern production and facilities & equipment; the most-cited regulation is 21 CFR 211.42 (design and construction features).
At a glance
Production and facilities & equipment account for 5 of 6 observations.
Most cited: 21 CFR 211.42 (2×) · 211.113 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the room and equipment…
- 02
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile do not include…
- 03
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are…
- 04
Aseptic processing areas are deficient regarding the system…
This inspection in context
Christopher R. Czajka
37 documents · 2015–2025
Cites FDCA 501(a)(2)(A) (insanitary conditions) more than any other section. Most of their documents are for sites in California.
The firmBallard Plaza Pharmacy I, Inc. history
All 3 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.42
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Ballard Plaza Pharmacy I, Inc.?
FDA listed 6 observations on this Form 483, mostly about production, facilities & equipment and laboratory controls. The most-cited regulation is 21 CFR 211.42 (design and construction features). The opening words of each observation are shown on this page.
Who inspected Ballard Plaza Pharmacy I, Inc.?
Christopher R. Czajka, Gary C. Pecic, Gerard P. De Leon and Lisa T. Michel are named on this Form 483, for the inspection of Apr 25 – May 17, 2016. Each investigator has a profile showing what they cite most.
When was Ballard Plaza Pharmacy I, Inc. inspected by FDA?
The inspection ran Apr 25 – May 17, 2016, and the Form 483 is dated June 10, 2016.
How do I get the full Form 483 for Ballard Plaza Pharmacy I, 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.