Hawaii Health Systems Corporation dba Kona Community Hospital Pharmacy
FDA inspection history in Kealakekua, Hawaii, 2019 to 2021
- 1
- Warning letter
- 1
- Form 483
- 1
- Close-out
Every document, by year
- Warning letter
- Form 483
- Close-out
2019: one Form 483; 2021: one warning letter.
The story so far
Built from the dates and citations on the documents themselves.
- 2019–21One Form 483 and one warning letter, at Kealakekua, Hawaii.
Cited most
Across all Hawaii Health Systems Corporation dba Kona Community Hospital Pharmacy observations on file
- 21 CFR 211.113Control of microbiological contamination3
- 21 CFR 211.42Design and construction features3
- 21 CFR 211.28Personnel responsibilities1
- 21 CFR 211.46Ventilation, air filtration, air heating and cooling1
The complete Hawaii Health Systems Corporation dba Kona Community Hospital Pharmacy file.
All 3 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
The price of the documents, added to your cart together
Sites
Kealakekua, Hawaii
One warning letter, one Form 483 and one close-out letter · 2019 to 2021 · 8 observations
Latest: Warning letter, Feb 1, 2021 →
Documents
3 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2021-02-01 | Warning letter Warning letter | Kealakekua, Hawaii | — | $99 |
| 2019-12-13 | 483 Form 483 | Kealakekua, Hawaii | 8 | $99 |
| Undated | Close-out Close-out letter | Kealakekua, Hawaii | — | $99 |
Investigators on these documents
FEI number 3006684882 · most recent document Feb 1, 2021
About Hawaii Health Systems Corporation dba Kona Community Hospital Pharmacy
How many FDA Form 483s has Hawaii Health Systems Corporation dba Kona Community Hospital Pharmacy received?
FDA Intel has 1 Form 483 on file for Hawaii Health Systems Corporation dba Kona Community Hospital Pharmacy; the most recent is dated Dec 13, 2019.
When was Hawaii Health Systems Corporation dba Kona Community Hospital Pharmacy last inspected by FDA?
The most recent FDA inspection document on file for Hawaii Health Systems Corporation dba Kona Community Hospital Pharmacy is a Form 483 dated Dec 13, 2019, for the site in Kealakekua, Hawaii.
What did FDA cite at Hawaii Health Systems Corporation dba Kona Community Hospital Pharmacy?
The regulations cited most in the observations on file for Hawaii Health Systems Corporation dba Kona Community Hospital Pharmacy are 21 CFR 211.113 (Control of microbiological contamination), 3 times; 21 CFR 211.42 (Design and construction features), 3 times; 21 CFR 211.28 (Personnel responsibilities), 1 time.
Has Hawaii Health Systems Corporation dba Kona Community Hospital Pharmacy received an FDA warning letter?
Yes. FDA Intel has 1 FDA warning letter on file for Hawaii Health Systems Corporation dba Kona Community Hospital Pharmacy; the most recent is dated Feb 1, 2021.