FDA Inspection
Rising Pharma Holdings, IncRising Pharma Holdings, Inc – FDA Inspection, Jun 30, 2009
Record Details
This FDA Inspection record concerns Rising Pharma Holdings, Inc, with an inspection on June 30, 2009, issued by the Center for Veterinary Medicine, covering veterinary.
- Company
- Rising Pharma Holdings, Inc
- Inspection Date
- June 30, 2009
- Product Type
- Veterinary
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ID · 6600b478-4ab0-41a2-b023-eb320e4271e9
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 594540
- FDA center
- Animal Drugs & Feeds
- Project area
- Monitoring of Marketed Animal Drugs, Feed, and Devices
FDA Citations
14- 21 CFR 211.188(b)(12)Investigations made into any unexplained discrepancy
- 21 CFR 211.198(a)Adverse Drug Experience
- 21 CFR 211.84(d)(2)Testing Each Component for Conformity with Specs
- 21 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
- 21 CFR 211.84(e)Rejecting When Specifications Not Met
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.113(b)Validation lacking for sterile drug products
- 21 CFR 211.67(b)(3)Cleaning SOPs/instructions
- 21 CFR 211.115(a)Reprocessing procedures not written or followed
- 21 CFR 211.68(a)Calibration/Inspection/Checking not done
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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 |
| April 26, 2017 | VAI | Chicago District Office | Pre-Approval Eval. of Animal Drugs and Food Additives |
| 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 |
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