Simpro, LLC
FDA inspection history in Irving, Texas, 2016
- 1
- Warning letter
- 1
- Form 483
Every document, by year
- Warning letter
- Form 483
2016: one warning letter and one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2016One warning letter and one Form 483, at Irving, Texas.
Cited most
Across all Simpro observations on file
- 21 CFR 803.17What are the requirements for developing, maintaining, and implementing written MDR procedures that apply to me?1
- 21 CFR 820.100Corrective and preventive action1
- 21 CFR 820.150Storage1
- 21 CFR 820.198Complaint files1
- 21 CFR 820.22Quality audit1
The complete Simpro 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
Irving, Texas
One warning letter and one Form 483 · 2016 · 5 observations
Latest: Warning letter, Aug 17, 2016 →
Documents
2 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2016-08-17 | Warning letter Warning letter | Irving, Texas | — | $99 |
| 2016-07-07 | 483 Form 483 | Irving, Texas | 5 | $99 |
Investigators on these documents
FEI number 3004485927 · most recent document Aug 17, 2016
About Simpro, LLC
How many FDA Form 483s has Simpro, LLC received?
FDA Intel has 1 Form 483 on file for Simpro, LLC; the most recent is dated Jul 7, 2016.
When was Simpro, LLC last inspected by FDA?
The most recent FDA inspection document on file for Simpro, LLC is a Form 483 dated Jul 7, 2016, for the site in Irving, Texas.
What did FDA cite at Simpro, LLC?
The regulations cited most in the observations on file for Simpro, LLC are 21 CFR 803.17 (What are the requirements for developing, maintaining, and implementing written MDR procedures that apply to me?), 1 time; 21 CFR 820.100 (Corrective and preventive action), 1 time; 21 CFR 820.150 (Storage), 1 time.
Has Simpro, LLC received an FDA warning letter?
Yes. FDA Intel has 1 FDA warning letter on file for Simpro, LLC; the most recent is dated Aug 17, 2016.