Abrams Royal Pharmacy
FDA inspection history in Dallas, Texas, 2013 to 2016
- 1
- Close-out
- 1
- Warning letter
- 1
- Form 483
Every document, by year
- Close-out
- Warning letter
- Form 483
2013: one Form 483; 2014: one warning letter; 2016: one close-out letter.
The story so far
Built from the dates and citations on the documents themselves.
- 2013–16One Form 483, one warning letter and one close-out letter, at Dallas, Texas.
Cited most
Across all Abrams Royal Pharmacy observations on file
- 21 CFR 211.42(a)Design and construction features3
- 21 CFR 211.160(b)General requirements2
- 21 CFR 211.113(b)Control of microbiological contamination1
- 21 CFR 211.166(a)Stability testing1
- 21 CFR 211.167(a)Special testing requirements1
The complete Abrams Royal 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
Dallas, Texas
One close-out letter, one warning letter and one Form 483 · 2013 to 2016 · 12 observations
Latest: Close-out, Sep 28, 2016 →
Documents
3 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2016-09-28 | Close-out Close-out letter | Dallas, Texas | — | $99 |
| 2014-07-14 | Warning letter Warning letter | Dallas, Texas | — | $99 |
| 2013-12-20 | 483 Form 483 | Dallas, Texas | 12 | $99 |
Investigators on these documents
FEI number 1000138425 · most recent document Sep 28, 2016
About Abrams Royal Pharmacy
How many FDA Form 483s has Abrams Royal Pharmacy received?
FDA Intel has 1 Form 483 on file for Abrams Royal Pharmacy; the most recent is dated Dec 20, 2013.
When was Abrams Royal Pharmacy last inspected by FDA?
The most recent FDA inspection document on file for Abrams Royal Pharmacy is a Form 483 dated Dec 20, 2013, for the site in Dallas, Texas.
What did FDA cite at Abrams Royal Pharmacy?
The regulations cited most in the observations on file for Abrams Royal Pharmacy are 21 CFR 211.42(a) (Design and construction features), 3 times; 21 CFR 211.160(b) (General requirements), 2 times; 21 CFR 211.113(b) (Control of microbiological contamination), 1 time.
Has Abrams Royal Pharmacy received an FDA warning letter?
Yes. FDA Intel has 1 FDA warning letter on file for Abrams Royal Pharmacy; the most recent is dated Jul 14, 2014.