FDA Inspection
Orion Corporation, Orion PharmaOrion Corporation, Orion Pharma – FDA Inspection, Jun 1, 2018
Record Details
This FDA Inspection record concerns Orion Corporation, Orion Pharma, with an inspection on June 1, 2018, issued by the Center for Drug Evaluation and Research, covering drugs.
- People
- Jogy George
- Rodney G. Raiford
View Company Profile
ID · 0d1b8e1b-f117-476b-882c-9cf511f0504d
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1053840
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
6- 21 CFR 211.63Equipment Design, Size and Location
- 21 CFR 211.25(a)GMP Training Frequency
- 21 CFR 211.113(b)Procedures for sterile drug products
- 21 CFR 211.42(c)(10)Aseptic Processing Area
- 21 CFR 211.188(b)(5)In-Process and Laboratory Control Results
- 21 CFR 211.192Investigations of discrepancies, failures
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Other FDA inspections of Orion Corporation, Orion Pharma
8| Date | Classification | Office | Project area |
|---|---|---|---|
| November 7, 2024 | Not classified | Office of Inspections and Investigations | |
| June 2, 2022 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| September 17, 2020 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| April 21, 2017 | VAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
| September 13, 2016 | VAI | Center for Veterinary Medicine | Monitoring of Marketed Animal Drugs, Feed, and Devices |
Other documents for Orion Corporation, Orion Pharma
- FDA Inspection 1310408 - 2024-11-07
- FDA Inspection 1218973 - 2022-06-02
- FDA Inspection 1156118 - 2020-09-17
- FDA Inspection 1012832 - 2017-04-21
- FDA Inspection 987011 - 2016-09-13
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