Overview
- 8 public-safe observations are available for this inspection.
- 8 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.
2 Jun 2026
21 CFR 211.160(b)
Scientifically sound laboratory controls
Cited by Justin A Boyd, Martin M Kimani
2 Jun 2026
21 CFR 211.170(b)
Annual visual exams of drug products
Cited by Justin A Boyd, Martin M Kimani
2 Jun 2026
21 CFR 211.192
Investigations of discrepancies, failures
Cited by Justin A Boyd, Martin M Kimani
2 Jun 2026
21 CFR 211.194(a)
Complete test data included in records
Cited by Justin A Boyd, Martin M Kimani
Inspected site
FMFresenius Medical Care Andina S.A.S.Cota, Colombia
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.100(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.160(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.170(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.194(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.42(c)(5) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.58 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.67(a) | Cited across public-safe Form 483 observations | 1x |
Full 483 report
Get the verbatim text of all 8 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