Overview
- 7 public-safe observations are available for this inspection.
- 7 structured CFR citations are represented.
- 2 investigators are tied to this Form 483.
Inspectional observations
Each observation cites the regulation FDA found the firm out of compliance with.
8 Aug 2024
21 CFR 820.198(a)
Lack of or inadequate complaint procedures
Cited by Jocelyn C Turner, Mary A Millner
8 Aug 2024
21 CFR 820.25(b)
Training - Lack of or inadequate procedures
Cited by Jocelyn C Turner, Mary A Millner
8 Aug 2024
21 CFR 820.30(f)
Design verification - Lack of or inadequate procedures
Cited by Jocelyn C Turner, Mary A Millner
8 Aug 2024
21 CFR 820.30(i)
Design changes - Lack of or Inadequate Procedures
Cited by Jocelyn C Turner, Mary A Millner
Inspected site
QMQapel Medical Inc.Fremont, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 820.198(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.25(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.30(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.30(f) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.30(i) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.40 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.50(a)(1) | Cited across public-safe Form 483 observations | 1x |
Source document
PDF
PDF available
Form 483 source document
The source document is available to authorized Atlas users.
Full 483 report
Get the verbatim text of all 7 observations
The source PDF, so your team sees exactly what was cited and how it was answered.
- The site's full inspection history around this Form 483
- Whether these citations escalated to a warning letter
- The investigators involved and the citations they repeat elsewhere