FDA Inspection
Kreitchman PET CenterKreitchman PET Center – FDA Inspection, Sep 13, 2019
Record Details
This FDA Inspection record concerns Kreitchman PET Center, with an inspection on September 13, 2019, issued by the New York District Office, covering human drugs.
- Office
- New York District Office
- People
- Dhanalakshm Kasi (Issuing Officer)
- Nicholas A. Violand (FDA Associated Person)
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ID · 984277d0-50a6-4e00-bbf9-efa0aa040046
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1101937
- FDA center
- Human Drugs
- Project area
- New Drug Evaluation
- Outcome
- Form 483 issued
FDA Citations
7- 21 CFR 212.20(d)Determination need for investigation
- 21 CFR 212.20(e)Written QA procedures established, followed
- 21 CFR 212.50(a)Written control procedures
- 21 CFR 212.50(b)(6)Action limits on radiochemical yield
- 21 CFR 212.60(a)Testing procedures
- 21 CFR 212.60(c)Analytical methods
- 21 CFR 212.60(d)Supplies adequately controlled
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Other FDA inspections of Kreitchman PET Center
2| Date | Classification | Office | Project area |
|---|---|---|---|
| September 2, 2025 | Not classified | New York District Office | Drug Quality Assurance |
| December 15, 2017 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
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