FDA Inspection
Patheon Softgels B.V.Patheon Softgels B.V. – FDA Inspection, Nov 30, 2018
Record Details
This FDA Inspection record concerns Patheon Softgels B.V., with an inspection on November 30, 2018, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · adc85fd8-5c9b-407e-b9a7-fa82f705d929
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1073073
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
4- 21 CFR 211.68(b)Computer control of master formula records
- 21 CFR 211.160(a)Lab controls established, including changes
- 21 CFR 211.192Investigations of discrepancies, failures
- 21 CFR 211.22(d)Procedures not in writing, fully followed
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Other FDA inspections of Patheon Softgels B.V.
3| Date | Classification | Office | Project area |
|---|---|---|---|
| May 17, 2023 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| June 20, 2014 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| March 14, 2012 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Patheon Softgels B.V.
- FDA Inspection 1261181 - 2023-05-17
- FDA Inspection 885869 - 2014-06-20
- FDA Inspection 774336 - 2012-03-14
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