FDA Inspection
Laboratoires Dermo-Cosmetik Inc.Laboratoires Dermo-Cosmetik Inc. – FDA Inspection, Sep 22, 2017
Record Details
This FDA Inspection record concerns Laboratoires Dermo-Cosmetik Inc., with an inspection on September 22, 2017, issued by the Center for Drug Evaluation and Research, covering drugs.
- Person
- Kara D. Dobbin (Issuing Officer)
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ID · bfbf13f9-7d07-44ed-8886-64afd89a897d
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1026116
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 211.68(b)Computer control of master formula records
- 21 CFR 211.22(d)Procedures not in writing, fully followed
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Other FDA inspections of Laboratoires Dermo-Cosmetik Inc.
2| Date | Classification | Office | Project area |
|---|---|---|---|
| June 10, 2022 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| March 19, 2015 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Laboratoires Dermo-Cosmetik Inc.
- FDA Inspection 1171675 - 2022-06-10
- FDA Inspection 923006 - 2015-03-19
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