American Specialty Pharmacy
FDA inspection history in Plano, Texas, 2014 to 2016
- 1
- Warning letter
- 1
- Form 483
Every document, by year
- Warning letter
- Form 483
2014: one Form 483; 2016: one warning letter.
The story so far
Built from the dates and citations on the documents themselves.
- 2014–16One Form 483 and one warning letter, at Plano, Texas.
Cited most
Across all American Specialty Pharmacy observations on file
- 21 CFR 211.42(c)(10)(iv)Design and construction features3
- 21 CFR 211.113(b)Control of microbiological contamination1
- 21 CFR 211.165(f)Testing and release for distribution1
- 21 CFR 211.166(a)Stability testing1
- 21 CFR 211.167(a)Special testing requirements1
The complete American Specialty Pharmacy file.
All 2 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
Plano, Texas
One warning letter and one Form 483 · 2014 to 2016 · 9 observations
Latest: Warning letter, Jun 28, 2016 →
Documents
2 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2016-06-28 | Warning letter Warning letter | Plano, Texas | — | $99 |
| 2014-12-19 | 483 Form 483 | Plano, Texas | 9 | $99 |
Investigators on these documents
FEI number 3010984686 · most recent document Jun 28, 2016
About American Specialty Pharmacy
How many FDA Form 483s has American Specialty Pharmacy received?
FDA Intel has 1 Form 483 on file for American Specialty Pharmacy; the most recent is dated Dec 19, 2014.
When was American Specialty Pharmacy last inspected by FDA?
The most recent FDA inspection document on file for American Specialty Pharmacy is a Form 483 dated Dec 19, 2014, for the site in Plano, Texas.
What did FDA cite at American Specialty Pharmacy?
The regulations cited most in the observations on file for American Specialty Pharmacy are 21 CFR 211.42(c)(10)(iv) (Design and construction features), 3 times; 21 CFR 211.113(b) (Control of microbiological contamination), 1 time; 21 CFR 211.165(f) (Testing and release for distribution), 1 time.
Has American Specialty Pharmacy received an FDA warning letter?
Yes. FDA Intel has 1 FDA warning letter on file for American Specialty Pharmacy; the most recent is dated Jun 28, 2016.