Scapa Tapes North America, LLC
Form 483 issued June 17, 2022 · Knoxville, Tennessee
- Inspection
- Jun 15 – Jun 17, 2022
- Investigators
- Benjamin E. Bowen· Christina L. Bigham
- Observations
- 1
- Pages
- 4
- FEI number
- 3015200795
In short: On June 17, 2022, FDA issued a Form 483 with 1 observation to Scapa Tapes North America, LLC in Knoxville, Tennessee (FEI 3015200795) after an inspection that ran Jun 15 – Jun 17, 2022. The investigators were Benjamin E. Bowen and Christina L. Bigham. Most observations concern records & documents; the most-cited regulation is 21 CFR 820.181 (device master record).
At a glance
1 of 1 observations on this 483 concern records & documents.
Most cited: 21 CFR 820.181 (1×)
What FDA observed
Preview: the opening words of each observation- 01
A device master record has…
This inspection in context
Benjamin E. Bowen
4 documents · 2021–2025
Cites 820.50 (purchasing controls) more than any other section. Most of their documents are for sites in Tennessee.
The firmScapa Tapes North America, LLC history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 820.181
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Scapa Tapes North America, LLC?
FDA listed 1 observation on this Form 483, mostly about records & documents. The most-cited regulation is 21 CFR 820.181 (device master record). The opening words of each observation are shown on this page.
Who inspected Scapa Tapes North America, LLC?
Benjamin E. Bowen and Christina L. Bigham are named on this Form 483, for the inspection of Jun 15 – Jun 17, 2022. Each investigator has a profile showing what they cite most.
When was Scapa Tapes North America, LLC inspected by FDA?
The inspection ran Jun 15 – Jun 17, 2022, and the Form 483 is dated June 17, 2022.
How do I get the full Form 483 for Scapa Tapes North America, 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.