Overview
- 6 public-safe observations are available for this inspection.
- 3 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.
5 Feb 2026
ISO 13485:2016 Clause 8.5.2
Corrective action procedures not documented
Cited by Alex J Wild
Inspected site
EMEcotec Manufacturing, Inc.Okeechobee, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| ISO 13485:2016 Clause 8.2.2 | Cited across public-safe Form 483 observations | 2x |
| ISO 13485:2016 Clause 8.3.4 | Cited across public-safe Form 483 observations | 2x |
| ISO 13485:2016 Clause 8.5.2 | Cited across public-safe Form 483 observations | 2x |
Source document
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Form 483 source document
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Full 483 report
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- 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