Overview
- 1 FDA inspection is on record.
- 1 inspection produced a Form 483.
- The most recent recorded inspection date is 2026-06-02.
At a glance
Inspections
1
Form 483s
1
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 26 May 2026 – 2 Jun 2026 | Human Drugs | 483 | View 483 → |
Observations on record
Form 483 observations cited at this site, most recent first.
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
Investigators
FDA investigators tied to this site in the record.
Justin A Boyd1 insp.
Martin M Kimani1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| 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 site report
Get the verbatim findings behind Fresenius Medical Care Andina S.A.S.'s 1 Form 483
Recurring CFR citations, so your team knows what this site gets cited for.
- The site's full inspection history, with every Form 483 and its outcome
- Warning letters and recalls tied to the company behind it
- Whether recurring CFR citations get closed out or repeat