Sterling Diagnostics, Inc
Form 483 issued July 28, 2016 · Sterling Heights, Michigan
- Inspection
- Jul 6 – Jul 28, 2016
- Investigator
- Amy S. Graf
- Observations
- 10
- Pages
- 10
- FEI number
- 1831796
In short: On July 28, 2016, FDA issued a Form 483 with 10 observations to Sterling Diagnostics, Inc in Sterling Heights, Michigan (FEI 1831796) after an inspection that ran Jul 6 – Jul 28, 2016. The investigator was Amy S. Graf. Most observations concern cAPA and records & documents; the most-cited regulation is 21 CFR 820.30 (design controls).
At a glance
CAPA and records & documents account for 6 of 10 observations.
What FDA observed
Preview: the opening words of each observation- 01
A process whose results cannot be fully verified by subsequent inspection and test has not been…
- 02
The design was not validated under actual…
- 03
Procedures for design change have not been established. Your firm has extended the expiration dates of…
- 04
Records of complaint investigations do…
This inspection in context
Amy S. Graf
3 documents · 2016–2019
Cites 820.198(a) (complaint files) more than any other section. Most of their documents are for sites in Michigan.
The firmSterling Diagnostics, Inc history
The site's inspection history, in date order.
Similar 483sOther sites cited under 820.75(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Sterling Diagnostics, Inc?
FDA listed 10 observations on this Form 483, mostly about cAPA, records & documents and production & process controls. The most-cited regulation is 21 CFR 820.30 (design controls). The opening words of each observation are shown on this page.
Who inspected Sterling Diagnostics, Inc?
Amy S. Graf is named on this Form 483, for the inspection of Jul 6 – Jul 28, 2016. Each investigator has a profile showing what they cite most.
When was Sterling Diagnostics, Inc inspected by FDA?
The inspection ran Jul 6 – Jul 28, 2016, and the Form 483 is dated July 28, 2016.
How do I get the full Form 483 for Sterling Diagnostics, Inc?
Download the original PDF from FDA Intel for $99, with no subscription. Your first Form 483 or letter is on us. You also get an invoice PDF with the order.