FDA Inspection 1052110 — MedStar Health RDRC
The FDA completed an inspection of MedStar Health RDRC on May 15, 2018 in Hyattsville, MD. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 11 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- May 15, 2018
- Fiscal Year
- 2018
- Product Type
- Drugs
- Project Area
- Bioresearch Monitoring
- Location
- Hyattsville, MD (United States)
Additional Details
Radioactive Drug Research Committee
Citations
| ID | CFR | Description |
|---|---|---|
| 17958 | 21 CFR 361.1(c)(2) | Signatures of RDRC Chairman |
| 17959 | 21 CFR 361.1(c)(2) | >50% of members not at RDRC meeting |
| 17961 | 21 CFR 361.1(c)(2) | RDRC has not kept minutes of its meetings |
| 17962 | 21 CFR 361.1(c)(2) | Numerical votes not in the minutes of any RDRC meetings |
| 17964 | 21 CFR 361.1(c)(2) | RDRC did not meet at least once each quarter |
| 17965 | 21 CFR 361.1(c)(3) | Annual reports not submitted to FDA |
| 17985 | 21 CFR 361.1(d)(7) | Scientific knowledge and benefit |
| 17991 | 21 CFR 361.1(d)(9) | Institutional Review Board (IRB) approved research |
| 17993 | 21 CFR 361.1(f)(1) | Packaging, labeling - Rx only |
| 17994 | 21 CFR 361.1(f)(2) | Label - For research use |
| 18016 | 21 CFR 361.1(b)(3)(i) | Limit of radiation dose |