FDA Inspection
Laboratorios Baxter S.A.Laboratorios Baxter S.A. – FDA Inspection, Jun 8, 2018
Record Details
This FDA Inspection record concerns Laboratorios Baxter S.A., with an inspection on June 8, 2018, issued by the Office of Inspections and Investigations, covering human drugs.
View Company Profile
ID · 31fc3462-3b02-4afa-9eaf-aa3f554a4f1e
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1055383
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
7- 21 CFR 211.110(a)Control procedures to monitor and validate performance
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.165(a)Testing and release for distribution
- 21 CFR 211.170(b)Annual visual exams of drug products
- 21 CFR 211.192Written record of investigation incomplete
- 21 CFR 211.22(b)Adequate lab facilities not available
- 21 CFR 211.68(a)Calibration/Inspection/Checking not done
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.