Davol Inc.
Form 483 issued February 7, 2017 · Warwick, Rhode Island
- Inspection
- Feb 1 – Feb 7, 2017
- Investigator
- Maryam Tabatabaie
- Observations
- 2
- Pages
- 3
In short: On February 7, 2017, FDA issued a Form 483 with 2 observations to Davol Inc. in Warwick, Rhode Island after an inspection that ran Feb 1 – Feb 7, 2017. The investigator was Maryam Tabatabaie. Most observations concern cAPA; the most-cited regulation is 21 CFR 803.50 (if I am a manufacturer, what reporting requirements apply to me?).
At a glance
2 of 2 observations on this 483 concern capa.
Most cited: 21 CFR 803.50 (1×) · 820.198 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
An MDR report was not submitted within 30 days of receiving or otherwise becoming aware of…
- 02
Complaints involving the possible failure of a device, labeling and packaging to meet any of its…
This inspection in context
Maryam Tabatabaie
11 documents · 2016–2024
Cites 820.198 (complaint files) more than any other section. Most of their documents are for sites in Rhode Island.
The firmDavol Inc. history
The site's inspection history, in date order.
Similar 483sOther sites cited under 803.50
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Davol Inc.?
FDA listed 2 observations on this Form 483, mostly about cAPA. The most-cited regulation is 21 CFR 803.50 (if I am a manufacturer, what reporting requirements apply to me?). The opening words of each observation are shown on this page.
Who inspected Davol Inc.?
Maryam Tabatabaie is named on this Form 483, for the inspection of Feb 1 – Feb 7, 2017. Each investigator has a profile showing what they cite most.
When was Davol Inc. inspected by FDA?
The inspection ran Feb 1 – Feb 7, 2017, and the Form 483 is dated February 7, 2017.
How do I get the full Form 483 for Davol 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.