FDA Inspection
Stephanie HillyardStephanie Hillyard – FDA Inspection, Jul 1, 2011
Record Details
This FDA Inspection record concerns Stephanie Hillyard, with an inspection on July 1, 2011, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Company
- Stephanie Hillyard
- Inspection Date
- July 1, 2011
- Product Type
- Biologics
View Company Profile
ID · 2c8191a6-019e-4629-b7a9-4b36f42e6ef9
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 731755
- FDA center
- Biologics
- Project area
- Human Cellular, Tissue, and Gene Therapies
FDA Citations
9- 21 CFR 1271.160(a)All core requirements covered in program
- 21 CFR 1271.270(b)Management system re: core CGTPs
- 21 CFR 1271.265(c)(1)Release of HCT/Ps by responsible person
- 21 CFR 1271.265(e)Documentation elements for activities
- 21 CFR 1271.195(d)Documentation not maintained
- 21 CFR 1271.170(b)Qualifications lacking
- 21 CFR 1271.265(f)Return to inventory--procedures
- 21 CFR 1271.320(a)Procedures re complaints
- 21 CFR 1271.265(e)Procedures and release criteria
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.