American Specialty Pharmacy
FDA inspection history across 3 sites, 2015 to 2018
- 2
- Close-outs
- 2
- Form 483s
- 1
- Warning letter
Every document, by year
- Close-out
- Form 483
- Warning letter
2015: one Form 483; 2017: one close-out letter and one warning letter; 2018: one close-out letter and one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2015–18Two Form 483s, two close-out letters and one warning letter, at Dallas, Texas; Farmers Branch, Texas and San Antonio, Texas.
- 2015The longest 483 on file: 10 observations over 6 pages at Dallas, Texas.
Cited most
Across all American Specialty Pharmacy observations on file
- 21 CFR 211.42(c)(10)Design and construction features4
- 21 CFR 211.113(b)Control of microbiological contamination2
- 21 CFR 211.192Production record review2
- 21 CFR 211.100Written procedures; deviations1
- 21 CFR 211.110(a)(5)Sampling and testing of in-process materials and drug products1
The complete American Specialty Pharmacy file.
All 5 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
15% off buying them one by one
Sites
Farmers Branch, Texas
Two close-out letters and one warning letter · 2017 to 2018
Latest: Close-out, Nov 7, 2018 →San Antonio, Texas
One Form 483 · 2018 · 6 observations
Latest: Form 483, Aug 23, 2018 →Dallas, Texas
One Form 483 · 2015 · 10 observations
Latest: Form 483, Aug 5, 2015 →
Documents
5 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2018-11-07 | Close-out Close-out letter | Farmers Branch, Texas | — | $99 |
| 2018-08-23 | 483 Form 483 | San Antonio, Texas | 6 | $99 |
| 2017-07-28 | Close-out Close-out letter | Farmers Branch, Texas | — | $99 |
| 2017-04-04 | Warning letter Warning letter | Farmers Branch, Texas | — | $99 |
| 2015-08-05 | 483 Form 483 | Dallas, Texas | 10 | $99 |
Investigators on these documents
Rumany C. Penn (1)Santos E. Camara (1)Vilmary Negron Rodriguez (1)
FEI number 3011677351 · most recent document Nov 7, 2018
About American Specialty Pharmacy
How many FDA Form 483s has American Specialty Pharmacy received?
FDA Intel has 2 Form 483s on file for American Specialty Pharmacy; the most recent is dated Aug 23, 2018.
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 Aug 23, 2018, for the site in San Antonio, 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) (Design and construction features), 4 times; 21 CFR 211.113(b) (Control of microbiological contamination), 2 times; 21 CFR 211.192 (Production record review), 2 times.
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 Apr 4, 2017.