Clear Image Device LLC
Form 483 issued August 20, 2015 · Ann Arbor, Michigan
- Inspection
- Aug 4 – Aug 20, 2015
- Investigator
- Deanna L. Lampley
- Observations
- 6
- Pages
- 3
- FEI number
- 3009884681
In short: On August 20, 2015, FDA issued a Form 483 with 6 observations to Clear Image Device LLC in Ann Arbor, Michigan (FEI 3009884681) after an inspection that ran Aug 4 – Aug 20, 2015. The investigator was Deanna L. Lampley. Most observations concern records & documents and design controls; the most-cited regulation is 21 CFR 820.184 (device history record).
At a glance
Observations span 4 systems, led by records & documents.
Most cited: 21 CFR 820.184 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Acceptance activities were not documented and maintained as part of…
- 02
Labels and labeling used for each finished product, lot, or batch, were not sufficiently…
- 03
The design history file was not established and does not demonstrate that the design was developed…
- 04
Quality audits have not…
This inspection in context
Deanna L. Lampley
2 documents · 2015
Cites 820.184 (device history record) more than any other section. Most of their documents are for sites in Michigan.
The firmClear Image Device LLC history
The site's inspection history, in date order.
Similar 483sOther sites cited under 820.184
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Clear Image Device LLC?
FDA listed 6 observations on this Form 483, mostly about records & documents, design controls and management controls. The most-cited regulation is 21 CFR 820.184 (device history record). The opening words of each observation are shown on this page.
Who inspected Clear Image Device LLC?
Deanna L. Lampley is named on this Form 483, for the inspection of Aug 4 – Aug 20, 2015. Each investigator has a profile showing what they cite most.
When was Clear Image Device LLC inspected by FDA?
The inspection ran Aug 4 – Aug 20, 2015, and the Form 483 is dated August 20, 2015.
How do I get the full Form 483 for Clear Image Device LLC?
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.