FDA Inspection
MedStar Health RDRCMedStar Health RDRC – FDA Inspection, May 15, 2018
Record Details
This FDA Inspection record concerns MedStar Health RDRC, with an inspection on May 15, 2018, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · 5c40ce6b-53a4-4cb0-aa64-35194d10c1d7
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1052110
- FDA center
- Human Drugs
- Project area
- Bioresearch Monitoring
- Outcome
- Form 483 issued
FDA Citations
11- 21 CFR 361.1(f)(2)Label - For research use
- 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(d)(9)Institutional Review Board (IRB) approved research
- 21 CFR 361.1(d)(7)Scientific knowledge and benefit
- 21 CFR 361.1(b)(3)(i)Limit of radiation dose
- 21 CFR 361.1(c)(2)RDRC has not kept minutes of its meetings
- 21 CFR 361.1(c)(2)RDRC did not meet at least once each quarter
- 21 CFR 361.1(c)(3)Annual reports not submitted to FDA
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