Apothecure, Inc.
FDA inspection history in Dallas, Texas, 2007 to 2013
- 3
- Form 483s
Every document, by year
- Form 483
2007: one Form 483; 2013: one amended 483 and one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2007One Form 483, at Dallas, Texas.
- 2013One amended 483 and one Form 483, at Dallas, Texas.
- 2013The longest 483 on file: 13 observations over 16 pages at Dallas, Texas.
Cited most
Across all Apothecure observations on file
- 21 CFR 211.165Testing and release for distribution5
- 21 CFR 211.113Control of microbiological contamination4
- 21 CFR 211.42(c)(10)(iv)Design and construction features4
- 21 CFR 211.166Stability testing3
- 21 CFR 211.186Master production and control records3
The complete Apothecure 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
Dallas, Texas
Two Form 483s and one amended 483 · 2007 to 2013 · 39 observations
Latest: Form 483, Apr 17, 2013 →
Documents
3 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2013-04-17 | Amended 483 Amended 483 | Dallas, Texas | 13 | $99 |
| 2013-04-16 | 483 Form 483 | Dallas, Texas | 13 | $99 |
| 2007-08-13 | 483 Form 483 | Dallas, Texas | 13 | $99 |
Investigators on these documents
Jamillah Selby (2)John T. Chapman (2)Stephen D. Brown (2)Jean M. Cook (1)
FEI number 3000203232 · most recent document Apr 17, 2013
About Apothecure, Inc.
How many FDA Form 483s has Apothecure, Inc. received?
FDA Intel has 3 Form 483s on file for Apothecure, Inc.; the most recent is dated Apr 17, 2013.
When was Apothecure, Inc. last inspected by FDA?
The most recent FDA inspection document on file for Apothecure, Inc. is a Form 483 dated Apr 17, 2013, for the site in Dallas, Texas.
What did FDA cite at Apothecure, Inc.?
The regulations cited most in the observations on file for Apothecure, Inc. are 21 CFR 211.165 (Testing and release for distribution), 5 times; 21 CFR 211.113 (Control of microbiological contamination), 4 times; 21 CFR 211.42(c)(10)(iv) (Design and construction features), 4 times.