Overview
- 3 FDA inspections are on record.
- 3 inspections produced a Form 483.
- The most recent recorded inspection date is 2025-01-23.
At a glance
Inspections
3
Form 483s
3
EIRs
1
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 21 Jan 2025 – 23 Jan 2025 | Human Drugs | 483 | View 483 → |
| 15 Jun 2022 – 17 Jun 2022 | Medical Devices & Rad Health | 483 | View 483 → |
| 4 Feb 2020 – 7 Feb 2020 | Human Drugs | 483 | View 483 → |
Observations on record
Form 483 observations cited at this site, most recent first.
Approval and review of procedures
Cited by Ronda R Loyd Jones, Milton J De Jesus Tavarez, Mickell Smith
Written in-process control procedures
Cited by Ronda R Loyd Jones, Milton J De Jesus Tavarez, Mickell Smith
Following/documenting laboratory controls
Cited by Ronda R Loyd Jones, Milton J De Jesus Tavarez, Mickell Smith
Procedures not in writing, fully followed
Cited by Ronda R Loyd Jones, Milton J De Jesus Tavarez, Mickell Smith
DMR - not or inadequately maintained
Cited by Christina L Bigham, Benjamin E Bowen
Investigators
FDA investigators tied to this site in the record.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.100(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.110(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.160(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.186(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.188(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.22(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.181 | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Scapa Tapes North America, LLC's 3 Form 483s
Source PDFs and recurring CFR citations, so your team knows what this site gets cited for.
- The site's full inspection history, with every Form 483 and its outcome
- Warning letters and recalls tied to the company behind it
- Whether recurring CFR citations get closed out or repeat