FDA Inspection
Memorial Sloan-Kettering Cancer Center RDRCMemorial Sloan-Kettering Cancer Center RDRC – FDA Inspection, Jun 15, 2017
Record Details
This FDA Inspection record concerns Memorial Sloan-Kettering Cancer Center RDRC, with an inspection on June 15, 2017, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · 1c599cbd-fa0d-4cec-9a59-a88ab2267903
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1016008
- FDA center
- Human Drugs
- Project area
- Bioresearch Monitoring
- Outcome
- Form 483 issued
FDA Citations
9- 21 CFR 361.1(f)(2)Label - For research use
- 21 CFR 361.1(f)(9)Label - Name, address manufacturer
- 21 CFR 361.1(f)(4)Label - Established name, quantity active ingredient
- 21 CFR 361.1(f)(1)Packaging, labeling - Rx only
- 21 CFR 361.1(f)(11)Label - Parenteral drug, sterile
- 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)(2)RDRC has not kept minutes of its meetings
- 21 CFR 361.1(c)(2)Representation of the required fields of expertise
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Other FDA inspections of Memorial Sloan-Kettering Cancer Center RDRC
1| Date | Classification | Office | Project area |
|---|---|---|---|
| September 15, 2023 | NAI | Center for Devices and Radiological Health | Bioresearch Monitoring |
Other documents for Memorial Sloan-Kettering Cancer Center RDRC
- FDA Inspection 1218715 - 2023-09-15
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