FDA Inspection
ImprimisRx NJImprimisRx NJ – FDA Inspection, Sep 30, 2015
Record Details
This FDA Inspection record concerns ImprimisRx NJ, with an inspection on September 30, 2015, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- ImprimisRx NJ
- Inspection Date
- September 30, 2015
- Product Type
- Drugs
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ID · c1ff47db-9883-46a3-b468-9ecb8b2bb528
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 945463
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
3- 21 CFR 211.166(b)Adequate number of batches on stability
- 21 CFR 211.42(c)(10)(iv)Environmental Monitoring System
- 21 CFR 211.113(b)Procedures for sterile drug products
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Other FDA inspections of ImprimisRx NJ
5| Date | Classification | Office | Project area |
|---|---|---|---|
| August 5, 2022 | OAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| April 9, 2019 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| July 10, 2017 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| July 2, 2014 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| August 19, 2013 | OAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for ImprimisRx NJ
- FDA Inspection 1177284 - 2022-08-05
- FDA Inspection 1087778 - 2019-04-09
- FDA Inspection 1027726 - 2017-07-10
- FDA Inspection 886479 - 2014-07-02
- FDA Inspection 845707 - 2013-08-19
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