FDA Inspection
Ernest Orlando Lawrence Berkeley National Laboratory RDRCErnest Orlando Lawrence Berkeley National Laboratory RDRC – FDA Inspection, Sep 21, 2017
Record Details
This FDA Inspection record concerns Ernest Orlando Lawrence Berkeley National Laboratory RDRC, with an inspection on September 21, 2017, issued by the Center for Drug Evaluation and Research, covering drugs.
- Inspection Date
- September 21, 2017
- Product Type
- Drugs
- Person
- Sandra S. Saniga (Issuing Officer)
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ID · 42f20c07-48ec-4242-b2ac-9126a666a5e6
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1025976
- FDA center
- Human Drugs
- Project area
- Bioresearch Monitoring
- Outcome
- Form 483 issued
FDA Citations
6- 21 CFR 361.1(f)(5)Label - radioactivity, amount
- 21 CFR 361.1(f)(1)Packaging, labeling - Rx only
- 21 CFR 361.1(c)(2)Numerical votes not in the minutes of any RDRC meetings
- 21 CFR 361.1(c)(2)Signatures of RDRC Chairman
- 21 CFR 361.1(c)(3)FDA research proposals not reported +30 subjects
- 21 CFR 361.1(c)(2)RDRC did not meet at least once each quarter
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