FDA Inspection
Vero Biotech IncVero Biotech Inc – FDA Inspection, Nov 16, 2018
Record Details
This FDA Inspection record concerns Vero Biotech Inc, with an inspection on November 16, 2018, issued by the Atlanta District Office, covering human drugs.
- Office
- Atlanta District Office
- People
- Steven B. Hertz (Issuing Officer)
- Tamara J. Henderson (FDA Associated Person)
- Veronica Fuentes (FDA Associated Person)
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ID · b093b72e-ab0e-408d-b107-ae167361fea3
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1074412
- FDA center
- Human Drugs
- Project area
- New Drug Evaluation
- Outcome
- Form 483 issued
FDA Citations
7- 21 CFR 211.100(b)SOPs not followed / documented
- 21 CFR 211.101(d)Component addition checked by 2nd person
- 21 CFR 211.113(a)Procedures for non-sterile drug products
- 21 CFR 211.166(a)Lack of written stability program
- 21 CFR 211.68(b)Computer control of master formula records
- 21 CFR 820.170(a)Lack of or inadequate instructions
- 21 CFR 820.20(d)Quality plan
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Other FDA inspections of Vero Biotech Inc
1| Date | Classification | Office | Project area |
|---|---|---|---|
| August 12, 2022 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
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