FDA Inspection
Velocity Production and PackagingVelocity Production and Packaging – FDA Inspection, May 8, 2019
Record Details
This FDA Inspection record concerns Velocity Production and Packaging, with an inspection on May 8, 2019, issued by the Center for Drug Evaluation and Research, covering drugs.
View Company Profile
ID · 4b018373-f758-478d-8245-d49dc2776d9c
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1092083
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
9- 21 CFR 211.110(a)Control procedures to monitor and validate performance
- 21 CFR 211.25(a)Training--operations, GMPs, written procedures
- 21 CFR 211.188(b)Batch production and Batch Control Record Requirements
- 21 CFR 211.160(a)Lab controls established, including changes
- 21 CFR 211.192Investigations of discrepancies, failures
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.134(c)Examinations documented
- 21 CFR 211.166(a)(3)Valid stability test methods
- 21 CFR 211.67(b)Written procedures not established/followed
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.