Scapa Tapes North America, LLC
Form 483 issued January 23, 2025 · Knoxville, Tennessee
- Inspection
- Jan 21 – Jan 23, 2025
- Investigators
- Mickell Smith· Ronda R. Loyd Jones
- Observations
- 4
- Pages
- 3
- FEI number
- 3015200795
In short: On January 23, 2025, FDA issued a Form 483 with 4 observations to Scapa Tapes North America, LLC in Knoxville, Tennessee (FEI 3015200795) after an inspection that ran Jan 21 – Jan 23, 2025. The investigators were Mickell Smith and Ronda R. Loyd Jones. Most observations concern production and quality system.
At a glance
Production and quality system account for 3 of 4 observations.
What FDA observed
Preview: the opening words of each observation- 01
The responsibilities and procedures applicable to the quality control unit…
- 02
Written procedures are not followed that describe the in-process controls and tests to be conducted on…
- 03
Established standards, test procedures and laboratory control mechanisms are not followed and documented…
- 04
Written procedures are not drafted, reviewed and approved by…
This inspection in context
Mickell Smith
4 documents · 2025–2026
Cites 211.22(a) (responsibilities of quality control unit) more than any other section. Most of their documents are for sites in Florida.
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 211.22(d)
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 4 observations on this Form 483, mostly about production, quality system and laboratory controls. The opening words of each observation are shown on this page.
Who inspected Scapa Tapes North America, LLC?
Mickell Smith and Ronda R. Loyd Jones are named on this Form 483, for the inspection of Jan 21 – Jan 23, 2025. Each investigator has a profile showing what they cite most.
When was Scapa Tapes North America, LLC inspected by FDA?
The inspection ran Jan 21 – Jan 23, 2025, and the Form 483 is dated January 23, 2025.
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.