FDA Inspection
bene PharmaChem GmbH Co.KGbene PharmaChem GmbH Co.KG – FDA Inspection, Nov 8, 2018
Record Details
This FDA Inspection record concerns bene PharmaChem GmbH Co.KG, with an inspection on November 8, 2018, issued by the Center for Drug Evaluation and Research, covering drugs.
- Person
- Yumi J. Hiramine (Issuing Officer)
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ID · 5cb5269d-bd73-4045-98c7-84d28adb0a68
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1078099
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
Other FDA inspections of bene PharmaChem GmbH Co.KG
3| Date | Classification | Office | Project area |
|---|---|---|---|
| May 21, 2014 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| July 8, 2011 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| October 23, 2008 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for bene PharmaChem GmbH Co.KG
- FDA Inspection 882731 - 2014-05-21
- FDA Inspection 739379 - 2011-07-08
- FDA Inspection 546262 - 2008-10-23
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