FDA Inspection
Rising Pharma Holdings, IncRising Pharma Holdings, Inc – FDA Inspection, Apr 26, 2017
Record Details
This FDA Inspection record concerns Rising Pharma Holdings, Inc, with an inspection on April 26, 2017, issued by the Chicago District Office, covering animal drugs & feeds.
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ID · 9cb56091-c2b0-46b3-b243-5e0e86ce370b
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1015589
- FDA center
- Animal Drugs & Feeds
- Project area
- Pre-Approval Eval. of Animal Drugs and Food Additives
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 211.113(b)Validation lacking for sterile drug products
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.63Equipment Design, Size and Location
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Other FDA inspections of Rising Pharma Holdings, Inc
16| Date | Classification | Office | Project area |
|---|---|---|---|
| April 8, 2022 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| May 16, 2018 | OAI | Center for Veterinary Medicine | Monitoring of Marketed Animal Drugs, Feed, and Devices |
| December 9, 2016 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| June 10, 2016 | OAI | Center for Devices and Radiological Health | Compliance: Devices |
| June 6, 2014 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
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