FDA Inspection
Cornerstone Laboratories LLCCornerstone Laboratories LLC – FDA Inspection, Jan 19, 2023
Record Details
This FDA Inspection record concerns Cornerstone Laboratories LLC, with an inspection on January 19, 2023, issued by the Center for Drug Evaluation and Research, covering drugs.
View Company Profile
ID · 086246c5-e5b0-4ec1-a12e-ee805023081e
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1195175
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
10- 21 CFR 211.68(b)Computer control of master formula records
- 21 CFR 211.25(a)Training--operations, GMPs, written procedures
- 21 CFR 211.194(a)(4)Complete Test Data
- 21 CFR 211.160(b)(4)Calibration - at intervals, written program, remedial action
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.160(b)(4)Calibration - at intervals, written program, remedial action
- 21 CFR 211.194(a)(4)Complete Test Data
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.25(a)Training--operations, GMPs, written procedures
- 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.