FDA Inspection
FRESENIUS MEDICAL CARE ANDINA S A SFRESENIUS MEDICAL CARE ANDINA S A S – FDA Inspection, Jun 2, 2026
Record Details
This FDA Inspection record concerns FRESENIUS MEDICAL CARE ANDINA S A S, with an inspection on June 2, 2026, issued by the Office of Inspections and Investigations, covering human drugs.
View Company Profile
ID · cfef76a9-bc96-45e3-985b-1fc37970747e
Inspection Facts
- Inspection number
- 1321110
- FDA center
- Human Drugs
- Project area
- New Drug Evaluation
- Outcome
- Form 483 issued, view the record
FDA Citations
8- 21 CFR 211.100(a)Absence of Written Procedures
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.170(b)Annual visual exams of drug products
- 21 CFR 211.192Investigations of discrepancies, failures
- 21 CFR 211.194(a)Complete test data included in records
- 21 CFR 211.42(c)(5)Mfg / Processing Operations Area
- 21 CFR 211.58Buildings not maintained in good state of repair
- 21 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
Full citation text and observation details available on the Dashboard.
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.