FDA Inspection
Rising Pharma Holdings, IncRising Pharma Holdings, Inc – FDA Inspection, Sep 17, 2010
Record Details
This FDA Inspection record concerns Rising Pharma Holdings, Inc, with an inspection on September 17, 2010, issued by the Center for Veterinary Medicine, covering veterinary.
- Company
- Rising Pharma Holdings, Inc
- Inspection Date
- September 17, 2010
- Product Type
- Veterinary
View Company Profile
ID · e80b39d2-0265-41b7-9cfe-01ca8e931030
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 678441
- FDA center
- Animal Drugs & Feeds
- Project area
- Monitoring of Marketed Animal Drugs, Feed, and Devices
FDA Citations
9- 21 CFR 211.137(a)Expiration date lacking
- 21 CFR 211.165(f)Failing drug products not rejected
- 21 CFR 211.84(a)Components withheld from use pending release
- 21 CFR 211.84(e)Rejecting When Specifications Not Met
- 21 CFR 211.186(b)(9)Manufacturing Instructions and Specifications
- 21 CFR 211.192Investigations of discrepancies, failures
- 21 CFR 211.80(a)Procedures To Be in Writing
- 21 CFR 211.100(b)SOPs not followed / documented
- 21 CFR 211.192Written record of investigation incomplete
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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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