Overview
- 5 public-safe observations are available for this inspection.
- 5 structured CFR citations are represented.
- 1 investigator is tied to this Form 483.
Inspectional observations
Each observation cites the regulation FDA found the firm out of compliance with.
2 Sep 2022
21 CFR 820.20(c)
Management review - defined interval, sufficient frequency
Cited by Charles L Larson
2 Sep 2022
21 CFR 820.30(i)
Design changes - Lack of or Inadequate Procedures
Cited by Charles L Larson
2 Sep 2022
21 CFR 820.50(a)
Evaluation of suppliers, contractors, etc., requirements
Cited by Charles L Larson
2 Sep 2022
21 CFR 820.80(b)
Lack of or inadequate receiving acceptance procedures
Cited by Charles L Larson
Inspected site
MIMeditherm Inc.Albuquerque, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 820.20(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.22 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.30(i) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.50(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.80(b) | Cited across public-safe Form 483 observations | 1x |
Source document
PDF
PDF available
Form 483 source document
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Full 483 report
Get the verbatim text of all 5 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