Walter's Pharmacy
FDA inspection history in Allentown, Pennsylvania, 2017 to 2020
- 1
- Form 483
- 1
- Close-out
- 1
- Warning letter
Every document, by year
- Form 483
- Close-out
- Warning letter
2017: one warning letter; 2018: one close-out letter; 2020: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2017–20One warning letter, one close-out letter and one Form 483, at Allentown, Pennsylvania.
Cited most
Across all Walter's Pharmacy observations on file
- 21 CFR 211.113Control of microbiological contamination1
- 21 CFR 211.166Stability testing1
- 21 CFR 211.28Personnel responsibilities1
- 21 CFR 211.42Design and construction features1
- 21 CFR 211.84Testing and approval or rejection of components, drug product containers, and closures1
The complete Walter's 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
Allentown, Pennsylvania
One Form 483, one close-out letter and one warning letter · 2017 to 2020 · 5 observations
Latest: Form 483, Feb 9, 2020 →
Documents
3 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2020-02-09 | 483 Form 483 | Allentown, Pennsylvania | 5 | $99 |
| 2018-05-09 | Close-out Close-out letter | Allentown, Pennsylvania | — | $99 |
| 2017-01-11 | Warning letter Warning letter | Allentown, Pennsylvania | — | $99 |
Investigators on these documents
FEI number 3004613997 · most recent document Feb 9, 2020
About Walter's Pharmacy
How many FDA Form 483s has Walter's Pharmacy received?
FDA Intel has 1 Form 483 on file for Walter's Pharmacy; the most recent is dated Feb 9, 2020.
When was Walter's Pharmacy last inspected by FDA?
The most recent FDA inspection document on file for Walter's Pharmacy is a Form 483 dated Feb 9, 2020, for the site in Allentown, Pennsylvania.
What did FDA cite at Walter's Pharmacy?
The regulations cited most in the observations on file for Walter's Pharmacy are 21 CFR 211.113 (Control of microbiological contamination), 1 time; 21 CFR 211.166 (Stability testing), 1 time; 21 CFR 211.28 (Personnel responsibilities), 1 time.
Has Walter's Pharmacy received an FDA warning letter?
Yes. FDA Intel has 1 FDA warning letter on file for Walter's Pharmacy; the most recent is dated Jan 11, 2017.