Sterling Diagnostics, Inc
FDA inspection history in Sterling Heights, Michigan, 2016
- 1
- Form 483
Every document, by year
- Form 483
2016: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2016One Form 483, at Sterling Heights, Michigan.
Cited most
Across all Sterling Diagnostics observations on file
- 21 CFR 820.198(b)Complaint files2
- 21 CFR 820.30(g)Design controls2
- 21 CFR 8201
- 21 CFR 820.181Device master record1
- 21 CFR 820.184Device history record1
The complete Sterling Diagnostics file.
All 1 documents as original PDFs. For supplier audits, diligence and inspection prep.
Sites
Sterling Heights, Michigan
One Form 483 · 2016 · 10 observations
Latest: Form 483, Jul 28, 2016 →
Documents
1 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2016-07-28 | 483 Form 483 | Sterling Heights, Michigan | 10 | $99 |
Investigators on these documents
FEI number 1831796 · most recent document Jul 28, 2016
About Sterling Diagnostics, Inc
How many FDA Form 483s has Sterling Diagnostics, Inc received?
FDA Intel has 1 Form 483 on file for Sterling Diagnostics, Inc; the most recent is dated Jul 28, 2016.
When was Sterling Diagnostics, Inc last inspected by FDA?
The most recent FDA inspection document on file for Sterling Diagnostics, Inc is a Form 483 dated Jul 28, 2016, for the site in Sterling Heights, Michigan.
What did FDA cite at Sterling Diagnostics, Inc?
The regulations cited most in the observations on file for Sterling Diagnostics, Inc are 21 CFR 820.198(b) (Complaint files), 2 times; 21 CFR 820.30(g) (Design controls), 2 times; 21 CFR 820, 1 time.