FDA Inspection
Eau Zone Huiles & Fragrances LeeEau Zone Huiles & Fragrances Lee – FDA Inspection, Dec 15, 2017
Record Details
This FDA Inspection record concerns Eau Zone Huiles & Fragrances Lee, with an inspection on December 15, 2017, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · b813ba03-027f-4d7d-962c-7722b5dbc738
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1035213
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
12- 21 CFR 211.166(b)Adequate number of batches on stability
- 21 CFR 211.150(b)Recall facilitation
- 21 CFR 211.160(b)(1)Determination of conformance
- 21 CFR 211.142(b)Storage under appropriate conditions
- 21 CFR 211.25(a)Training , Education , Experience overall
- 21 CFR 211.160(b)(4)Establishment of calibration procedures
- 21 CFR 211.67(b)(5)Cleaning SOPs/equipment protection
- 21 CFR 211.170(b)Annual visual exams of drug products
- 21 CFR 211.160(b)(1)Samples (various types) representative, identified properly
- 21 CFR 211.42(b)Adequate space lacking to prevent mix-ups and contamination
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Other FDA inspections of Eau Zone Huiles & Fragrances Lee
3| Date | Classification | Office | Project area |
|---|---|---|---|
| August 14, 2019 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| February 5, 2016 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| December 20, 2012 | VAI | Center for Food Safety and Applied Nutrition | Food Composition, Standards, Labeling and Econ |
Other documents for Eau Zone Huiles & Fragrances Lee
- FDA Inspection 1102752 - 2019-08-14
- FDA Inspection 959760 - 2016-02-05
- FDA Inspection 825746 - 2012-12-20
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