FDA Inspection
Centurion Laboratories Private LimitedCenturion Laboratories Private Limited – FDA Inspection, Oct 26, 2018
Record Details
This FDA Inspection record concerns Centurion Laboratories Private Limited, with an inspection on October 26, 2018, issued by the Office of Inspections and Investigations, covering human drugs.
View Company Profile
ID · b946fcae-2a3d-401a-941b-3b388d786911
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1069853
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
7- 21 CFR 211.100(a)Absence of Written Procedures
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.194(a)(4)Complete Test Data
- 21 CFR 211.25(a)Training , Education , Experience overall
- 21 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
- 21 CFR 211.67(b)Written procedures not established/followed
- 21 CFR 211.68(b)Computer control of master formula records
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.