Dorneyville Pharmacy
FDA inspection history across 2 sites, 2017 to 2020
- 2
- Warning letters
- 2
- Form 483s
Every document, by year
- Warning letter
- Form 483
2017: one warning letter; 2018: one Form 483; 2020: one warning letter and one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2017–20Two warning letters and two Form 483s, at Allentown, Pennsylvania and Pennsylvania.
- 2020The longest 483 on file: 14 observations over 8 pages at Allentown, Pennsylvania.
Cited most
Across all Dorneyville Pharmacy observations on file
- 21 CFR 211.113Control of microbiological contamination3
- 21 CFR 211.42Design and construction features2
- 21 CFR 211.84Testing and approval or rejection of components, drug product containers, and closures2
- 21 CFR 211.150Distribution procedures1
- 21 CFR 211.165Testing and release for distribution1
The complete Dorneyville Pharmacy file.
All 4 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
Allentown, Pennsylvania
Two Form 483s and one warning letter · 2017 to 2020 · 16 observations
Latest: Form 483, Feb 9, 2020 →Pennsylvania
One warning letter · 2020
Latest: Warning letter, Mar 4, 2020 →
Documents
4 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2020-03-04 | Warning letter Warning letter | Pennsylvania | — | $99 |
| 2020-02-09 | 483 Form 483 | Allentown, Pennsylvania | 14 | $99 |
| 2018-09-28 | 483 Form 483 | Allentown, Pennsylvania | 2 | $99 |
| 2017-02-07 | Warning letter Warning letter | Allentown, Pennsylvania | — | $99 |
Investigators on these documents
FEI number 3005231215 · most recent document Mar 4, 2020
About Dorneyville Pharmacy
How many FDA Form 483s has Dorneyville Pharmacy received?
FDA Intel has 2 Form 483s on file for Dorneyville Pharmacy; the most recent is dated Feb 9, 2020.
When was Dorneyville Pharmacy last inspected by FDA?
The most recent FDA inspection document on file for Dorneyville Pharmacy is a Form 483 dated Feb 9, 2020, for the site in Allentown, Pennsylvania.
What did FDA cite at Dorneyville Pharmacy?
The regulations cited most in the observations on file for Dorneyville Pharmacy are 21 CFR 211.113 (Control of microbiological contamination), 3 times; 21 CFR 211.42 (Design and construction features), 2 times; 21 CFR 211.84 (Testing and approval or rejection of components, drug product containers, and closures), 2 times.
Has Dorneyville Pharmacy received an FDA warning letter?
Yes. FDA Intel has 2 FDA warning letters on file for Dorneyville Pharmacy; the most recent is dated Mar 4, 2020.