Neuro Kinetics, Inc
FDA inspection history in Pittsburgh, Pennsylvania, 2015 to 2019
- 1
- Form 483
- 1
- Close-out
Every document, by year
- Form 483
- Close-out
2015: one close-out letter; 2019: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2015One close-out letter, at Pittsburgh, Pennsylvania.
- 2019One Form 483, at Pittsburgh, Pennsylvania.
Cited most
Across all Neuro Kinetics observations on file
- 21 CFR 820.30(g)Design controls2
- 21 CFR 820.80(b)Receiving, in-process, and finished device acceptance1
- 21 CFR 820.90(a)Nonconforming product1
The complete Neuro Kinetics 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
Pittsburgh, Pennsylvania
One Form 483 and one close-out letter · 2015 to 2019 · 4 observations
Latest: Form 483, Jul 2, 2019 →
Documents
2 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2019-07-02 | 483 Form 483 | Pittsburgh, Pennsylvania | 4 | $99 |
| 2015-12-08 | Close-out Close-out letter | Pittsburgh, Pennsylvania | — | $99 |
Investigators on these documents
FEI number 2519945 · most recent document Jul 2, 2019
About Neuro Kinetics, Inc
How many FDA Form 483s has Neuro Kinetics, Inc received?
FDA Intel has 1 Form 483 on file for Neuro Kinetics, Inc; the most recent is dated Jul 2, 2019.
When was Neuro Kinetics, Inc last inspected by FDA?
The most recent FDA inspection document on file for Neuro Kinetics, Inc is a Form 483 dated Jul 2, 2019, for the site in Pittsburgh, Pennsylvania.
What did FDA cite at Neuro Kinetics, Inc?
The regulations cited most in the observations on file for Neuro Kinetics, Inc are 21 CFR 820.30(g) (Design controls), 2 times; 21 CFR 820.80(b) (Receiving, in-process, and finished device acceptance), 1 time; 21 CFR 820.90(a) (Nonconforming product), 1 time.