FocusLaboratories
FDA inspection history in North Little Rock, Arkansas, 2011 to 2016
- 2
- Warning letters
- 1
- Form 483
Every document, by year
- Warning letter
- Form 483
2011: one warning letter; 2015: one Form 483; 2016: one warning letter.
The story so far
Built from the dates and citations on the documents themselves.
- 2011One warning letter, at North Little Rock, Arkansas.
- 2015–16One Form 483 and one warning letter, at North Little Rock, Arkansas.
Cited most
Across all FocusLaboratories observations on file
- 21 CFR 211.160General requirements1
- 21 CFR 211.165Testing and release for distribution1
- 21 CFR 211.166Stability testing1
- 21 CFR 211.170Reserve samples1
- 21 CFR 211.180General requirements1
The complete FocusLaboratories 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
North Little Rock, Arkansas
Two warning letters and one Form 483 · 2011 to 2016 · 10 observations
Latest: Warning letter, Jun 3, 2016 →
Documents
3 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2016-06-03 | Warning letter Warning letter | North Little Rock, Arkansas | — | $99 |
| 2015-02-05 | 483 Form 483 | North Little Rock, Arkansas | 10 | $99 |
| 2011-11-16 | Warning letter Warning letter | North Little Rock, Arkansas | — | $99 |
Investigators on these documents
FEI number 3008990081 · most recent document Jun 3, 2016
About FocusLaboratories
How many FDA Form 483s has FocusLaboratories received?
FDA Intel has 1 Form 483 on file for FocusLaboratories; the most recent is dated Feb 5, 2015.
When was FocusLaboratories last inspected by FDA?
The most recent FDA inspection document on file for FocusLaboratories is a Form 483 dated Feb 5, 2015, for the site in North Little Rock, Arkansas.
What did FDA cite at FocusLaboratories?
The regulations cited most in the observations on file for FocusLaboratories are 21 CFR 211.160 (General requirements), 1 time; 21 CFR 211.165 (Testing and release for distribution), 1 time; 21 CFR 211.166 (Stability testing), 1 time.
Has FocusLaboratories received an FDA warning letter?
Yes. FDA Intel has 2 FDA warning letters on file for FocusLaboratories; the most recent is dated Jun 3, 2016.