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.
13 May 2026
ISO 13485:2016 Clause 6.1(b)
Resources for meeting regulatory and customer requirements not provided
Cited by Felix J Marrero
13 May 2026
ISO 13485:2016 Clause 6.4.2
Arrangements for control of contaminated product not planned and documented
Cited by Felix J Marrero
13 May 2026
ISO 13485:2016 Clause 8.2.2
Complaint handling procedures not documented
Cited by Felix J Marrero
13 May 2026
ISO 13485:2016 Clause 8.5.2
Corrective action procedures not documented
Cited by Felix J Marrero
Inspected site
TMTheo Manufacturing BVMaastricht, Netherlands
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 803.17 | Cited across public-safe Form 483 observations | 1x |
| ISO 13485:2016 Clause 6.1(b) | Cited across public-safe Form 483 observations | 1x |
| ISO 13485:2016 Clause 6.4.2 | Cited across public-safe Form 483 observations | 1x |
| ISO 13485:2016 Clause 8.2.2 | Cited across public-safe Form 483 observations | 1x |
| ISO 13485:2016 Clause 8.5.2 | Cited across public-safe Form 483 observations | 1x |
Full 483 report
Get the verbatim text of all 5 observations
The full inspection record, as Atlas holds it, 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