Overview
- 1 public-safe observation is available for this inspection.
- 1 structured CFR citation is represented.
- 1 investigator is tied to this Form 483.
Inspectional observations
Each observation cites the regulation FDA found the firm out of compliance with.
16 Jun 2026
ISO 13485:2016 Clause 8.5.2
Corrective actions were unduly delayed
Cited by Brittany D Mccracken
Inspected site
TCTecan CDMO Solutions MH, CorpMorgan Hill, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| ISO 13485:2016 Clause 8.5.2 | Cited across public-safe Form 483 observations | 1x |
Full 483 report
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