Ballard Plaza Pharmacy I, Inc.
FDA inspection history in Seattle, Washington, 2016 to 2017
- 2
- Form 483s
- 1
- Warning letter
Every document, by year
- Warning letter
- Form 483
2016: two Form 483s; 2017: one warning letter.
The story so far
Built from the dates and citations on the documents themselves.
- 2016–17Two Form 483s and one warning letter, at Seattle, Washington.
- 2016The longest 483 on file: 7 observations over 10 pages at Seattle, Washington.
Cited most
Across all Ballard Plaza Pharmacy I observations on file
- 21 CFR 211.113Control of microbiological contamination4
- 21 CFR 211.42Design and construction features4
- 21 CFR 211.167Special testing requirements2
- 21 CFR 211.28Personnel responsibilities2
- 21 CFR 211.137Expiration dating1
The complete Ballard Plaza Pharmacy I 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
Seattle, Washington
Two Form 483s and one warning letter · 2016 to 2017 · 13 observations
Latest: Warning letter, Aug 1, 2017 →
Documents
3 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2017-08-01 | Warning letter Warning letter | Seattle, Washington | — | $99 |
| 2016-06-10 | 483 Form 483 | Seattle, Washington | 6 | $99 |
| 2016-05-17 | 483 Form 483 | Seattle, Washington | 7 | $99 |
Investigators on these documents
Christopher R. Czajka (2)Gary C. Pecic (2)Lisa T. Michel (2)De Leon (1)Gerard P. De Leon (1)
FEI number 3006317860 · most recent document Aug 1, 2017
About Ballard Plaza Pharmacy I, Inc.
How many FDA Form 483s has Ballard Plaza Pharmacy I, Inc. received?
FDA Intel has 2 Form 483s on file for Ballard Plaza Pharmacy I, Inc.; the most recent is dated Jun 10, 2016.
When was Ballard Plaza Pharmacy I, Inc. last inspected by FDA?
The most recent FDA inspection document on file for Ballard Plaza Pharmacy I, Inc. is a Form 483 dated Jun 10, 2016, for the site in Seattle, Washington.
What did FDA cite at Ballard Plaza Pharmacy I, Inc.?
The regulations cited most in the observations on file for Ballard Plaza Pharmacy I, Inc. are 21 CFR 211.113 (Control of microbiological contamination), 4 times; 21 CFR 211.42 (Design and construction features), 4 times; 21 CFR 211.167 (Special testing requirements), 2 times.
Has Ballard Plaza Pharmacy I, Inc. received an FDA warning letter?
Yes. FDA Intel has 1 FDA warning letter on file for Ballard Plaza Pharmacy I, Inc.; the most recent is dated Aug 1, 2017.