Elkhart Pharmacy
FDA inspection history in Elkhart, Texas, 2015 to 2017
- 1
- Warning letter
- 1
- Form 483
Every document, by year
- Warning letter
- Form 483
2015: one Form 483; 2017: one warning letter.
The story so far
Built from the dates and citations on the documents themselves.
- 2015–17One Form 483 and one warning letter, at Elkhart, Texas.
Cited most
Across all Elkhart Pharmacy observations on file
- 21 CFR 211.42(c)(10)(v)Design and construction features2
- 21 CFR 211.166(a)Stability testing1
- 21 CFR 211.28(a)Personnel responsibilities1
The complete Elkhart 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
Elkhart, Texas
One warning letter and one Form 483 · 2015 to 2017 · 4 observations
Latest: Warning letter, May 8, 2017 →
Documents
2 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2017-05-08 | Warning letter Warning letter | Elkhart, Texas | — | $99 |
| 2015-12-21 | 483 Form 483 | Elkhart, Texas | 4 | $99 |
Investigators on these documents
FEI number 3011870779 · most recent document May 8, 2017
About Elkhart Pharmacy
How many FDA Form 483s has Elkhart Pharmacy received?
FDA Intel has 1 Form 483 on file for Elkhart Pharmacy; the most recent is dated Dec 21, 2015.
When was Elkhart Pharmacy last inspected by FDA?
The most recent FDA inspection document on file for Elkhart Pharmacy is a Form 483 dated Dec 21, 2015, for the site in Elkhart, Texas.
What did FDA cite at Elkhart Pharmacy?
The regulations cited most in the observations on file for Elkhart Pharmacy are 21 CFR 211.42(c)(10)(v) (Design and construction features), 2 times; 21 CFR 211.166(a) (Stability testing), 1 time; 21 CFR 211.28(a) (Personnel responsibilities), 1 time.
Has Elkhart Pharmacy received an FDA warning letter?
Yes. FDA Intel has 1 FDA warning letter on file for Elkhart Pharmacy; the most recent is dated May 8, 2017.