FDA Inspection
Delpharm ToursDelpharm Tours – FDA Inspection, Jul 7, 2011
Record Details
This FDA Inspection record concerns Delpharm Tours, with an inspection on July 7, 2011, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Delpharm Tours
- Inspection Date
- July 7, 2011
- Product Type
- Drugs
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ID · e0b0aff1-e7c3-4d4a-8bb2-a56499e90db1
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 737246
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
5- 21 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
- 21 CFR 211.63Equipment Design, Size and Location
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.113(b)Validation lacking for sterile drug products
- 21 CFR 211.192Written record of investigation incomplete
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Delpharm Tours
2| Date | Classification | Office | Project area |
|---|---|---|---|
| June 11, 2021 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| May 13, 2016 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Delpharm Tours
- FDA Inspection 1235010 - 2021-06-11
- FDA Inspection 972700 - 2016-05-13
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