FDA Inspection
Xoma (US) LLCXoma (US) LLC – FDA Inspection, Nov 29, 2012
Record Details
This FDA Inspection record concerns Xoma (US) LLC, with an inspection on November 29, 2012, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Xoma (US) LLC
- Inspection Date
- November 29, 2012
- Product Type
- Drugs
View Company Profile
ID · d9648a77-ce52-40c7-bb16-61e24375522c
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 808192
- FDA center
- Human Drugs
- Project area
- Bioresearch Monitoring
FDA Citations
4- 21 CFR 314.80(c)(1)(i)Late submission of 15-day report
- 21 CFR 314.80(d)Failure to submit scientific article
- 21 CFR 314.80(j)Failure to maintain records
- 21 CFR 314.80(b)Failure to develop written procedures
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