FDA Inspection
Rpk Pharmaceuticals IncRpk Pharmaceuticals Inc – FDA Inspection, Oct 14, 2021
Record Details
This FDA Inspection record concerns Rpk Pharmaceuticals Inc, with an inspection on October 14, 2021, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Rpk Pharmaceuticals Inc
- Inspection Date
- October 14, 2021
- Product Type
- Drugs
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ID · 29b04edb-3611-4cb7-836f-566da8a56f09
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1155217
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
2- 21 CFR 211.67(b)(3)Cleaning SOPs/instructions
- 21 CFR 211.100(b)SOPs not followed / documented
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Other FDA inspections of Rpk Pharmaceuticals Inc
4| Date | Classification | Office | Project area |
|---|---|---|---|
| February 28, 2019 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| March 8, 2012 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| April 9, 2010 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| August 7, 2009 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Rpk Pharmaceuticals Inc
- FDA Inspection 1081636 - 2019-02-28
- FDA Inspection 771926 - 2012-03-08
- FDA Inspection 660576 - 2010-04-09
- FDA Inspection 603965 - 2009-08-07
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