Carestream Health, Inc
Form 483 issued August 15, 2018 · Rochester, New York
- Inspection
- Aug 13 – Aug 15, 2018
- Investigator
- Nicholas C. Mendiola
- Observations
- 3
- Pages
- 4
- FEI number
- 1317267
In short: On August 15, 2018, FDA issued a Form 483 with 3 observations to Carestream Health, Inc in Rochester, New York (FEI 1317267) after an inspection that ran Aug 13 – Aug 15, 2018. The investigator was Nicholas C. Mendiola. Most observations concern cAPA; the most-cited regulation is 21 CFR 820.90 (nonconforming product).
At a glance
2 of 3 observations on this 483 concern capa.
Most cited: 21 CFR 820.90(a) (1×) · 820.100(b) (1×)
What FDA observed
Preview: the opening words of each observation- 01
Procedures have not been adequately established to control product that does not…
- 02
Corrective and preventive action activities and/or results have not…
- 03
: Promised…
This inspection in context
Nicholas C. Mendiola
4 documents · 2015–2018
Cites 803.17 (what are the requirements for developing, maintaining, and implementing written mdr procedures that apply to me?) more than any other section. Most of their documents are for sites in New York.
The firmCarestream Health, Inc history
The site's inspection history, in date order.
Similar 483sOther sites cited under 820.90(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Carestream Health, Inc?
FDA listed 3 observations on this Form 483, mostly about cAPA. The most-cited regulation is 21 CFR 820.90 (nonconforming product). The opening words of each observation are shown on this page.
Who inspected Carestream Health, Inc?
Nicholas C. Mendiola is named on this Form 483, for the inspection of Aug 13 – Aug 15, 2018. Each investigator has a profile showing what they cite most.
When was Carestream Health, Inc inspected by FDA?
The inspection ran Aug 13 – Aug 15, 2018, and the Form 483 is dated August 15, 2018.
How do I get the full Form 483 for Carestream Health, 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.