Hawaii Health Systems Corporation dba Kona Community Hospital Pharmacy
Form 483 issued December 13, 2019 · Kealakekua, Hawaii
- Inspection
- Dec 2 – Dec 13, 2019
- Investigators
- Christopher R. Czajka· Marcus F. Yambot
- Observations
- 8
- Pages
- 7
- FEI number
- 3006684882
In short: On December 13, 2019, FDA issued a Form 483 with 8 observations to Hawaii Health Systems Corporation dba Kona Community Hospital Pharmacy in Kealakekua, Hawaii (FEI 3006684882) after an inspection that ran Dec 2 – Dec 13, 2019. The investigators were Christopher R. Czajka and Marcus F. Yambot. 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 8 of 8 observations.
Most cited: 21 CFR 211.113 (3×) · 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
You did not make adequate product evaluation and take remedial action where actionable microbial contamination was…
- 02
You did not make adequate product evaluation and take remedial action where actionable microbial contamination was…
- 03
Your facility design allowed the influx of poor quality air into…
- 04
Your facility was designed and/or operated in a way that permits poor flow…
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 firmHawaii Health Systems Corporation dba Kona Community Hospital Pharmacy history
All 3 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.113
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Hawaii Health Systems Corporation dba Kona Community Hospital Pharmacy?
FDA listed 8 observations on this Form 483, mostly about production and facilities & equipment. 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 Hawaii Health Systems Corporation dba Kona Community Hospital Pharmacy?
Christopher R. Czajka and Marcus F. Yambot are named on this Form 483, for the inspection of Dec 2 – Dec 13, 2019. Each investigator has a profile showing what they cite most.
When was Hawaii Health Systems Corporation dba Kona Community Hospital Pharmacy inspected by FDA?
The inspection ran Dec 2 – Dec 13, 2019, and the Form 483 is dated December 13, 2019.
How do I get the full Form 483 for Hawaii Health Systems Corporation dba Kona Community Hospital 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.