Hiers Enterprises, LLC dba Northwest Compounding Pharmacy
FDA inspection history in Roseburg, Oregon, 2018 to 2022
- 2
- Form 483s
- 1
- Warning letter
Every document, by year
- Warning letter
- Form 483
2018: one Form 483; 2021: one Form 483; 2022: one warning letter.
The story so far
Built from the dates and citations on the documents themselves.
- 2018One Form 483, at Roseburg, Oregon.
- 2018The longest 483 on file: 10 observations over 9 pages at Roseburg, Oregon.
- 2021–22One Form 483 and one warning letter, at Roseburg, Oregon.
Cited most
Across all Hiers Enterprises, LLC dba Northwest Compounding Pharmacy observations on file
- 21 CFR 211.42Design and construction features3
- FDCA 501(a)(2)(A)Insanitary conditions3
- 21 CFR 211.165Testing and release for distribution2
- 21 CFR 211.113Control of microbiological contamination1
- 21 CFR 211.166Stability testing1
The complete Hiers Enterprises, LLC dba Northwest Compounding 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
Roseburg, Oregon
Two Form 483s and one warning letter · 2018 to 2022 · 13 observations
Latest: Warning letter, Sep 22, 2022 →
Documents
3 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2022-09-22 | Warning letter Warning letter | Roseburg, Oregon | — | $99 |
| 2021-11-10 | 483 Form 483 | Roseburg, Oregon | 3 | $99 |
| 2018-11-14 | 483 Form 483 | Roseburg, Oregon | 10 | $99 |
Investigators on these documents
FEI number 3014745182 · most recent document Sep 22, 2022
About Hiers Enterprises, LLC dba Northwest Compounding Pharmacy
How many FDA Form 483s has Hiers Enterprises, LLC dba Northwest Compounding Pharmacy received?
FDA Intel has 2 Form 483s on file for Hiers Enterprises, LLC dba Northwest Compounding Pharmacy; the most recent is dated Nov 10, 2021.
When was Hiers Enterprises, LLC dba Northwest Compounding Pharmacy last inspected by FDA?
The most recent FDA inspection document on file for Hiers Enterprises, LLC dba Northwest Compounding Pharmacy is a Form 483 dated Nov 10, 2021, for the site in Roseburg, Oregon.
What did FDA cite at Hiers Enterprises, LLC dba Northwest Compounding Pharmacy?
The regulations cited most in the observations on file for Hiers Enterprises, LLC dba Northwest Compounding Pharmacy are 21 CFR 211.42 (Design and construction features), 3 times; FDCA 501(a)(2)(A) (Insanitary conditions), 3 times; 21 CFR 211.165 (Testing and release for distribution), 2 times.
Has Hiers Enterprises, LLC dba Northwest Compounding Pharmacy received an FDA warning letter?
Yes. FDA Intel has 1 FDA warning letter on file for Hiers Enterprises, LLC dba Northwest Compounding Pharmacy; the most recent is dated Sep 22, 2022.