FDA Inspection
Scilabs PharmaceuticalsScilabs Pharmaceuticals – FDA Inspection, Oct 25, 2013
Record Details
This FDA Inspection record concerns Scilabs Pharmaceuticals, with an inspection on October 25, 2013, issued by the Center for Food Safety and Applied Nutrition, covering food/cosmetics.
- Company
- Scilabs Pharmaceuticals
- Inspection Date
- October 25, 2013
- Product Type
- Food/cosmetics
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ID · dfee64af-05c6-461a-aeb9-306fdd0cf0b7
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 853965
- FDA center
- Foods & Cosmetics
- Project area
- Food Composition, Standards, Labeling and Econ
FDA Citations
10- 21 CFR 111.12(c)Personnel - education, training, experience
- 21 CFR 111.27(b)Instruments - calibration
- 21 CFR 111.75(a)(1)(i)Component - verify identity, dietary ingredient
- 21 CFR 111.70(e)Specifications - contamination limits
- 21 CFR 111.103Written procedures - quality control operations
- 21 CFR 111.610(a)Records - available; FDA
- 21 CFR 111.205(a)Master manufacturing record - each batch
- 21 CFR 111.75(a)(2)(ii)(A)Component - qualify supplier
- 21 CFR 111.75(c)Specifications met - verify; finished batch
- 21 CFR 111.255(b)Batch record - complete
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Other FDA inspections of Scilabs Pharmaceuticals
2| Date | Classification | Office | Project area |
|---|---|---|---|
| February 4, 2014 | OAI | Center for Food Safety and Applied Nutrition | Food Composition, Standards, Labeling and Econ |
| August 14, 2012 | OAI | Center for Food Safety and Applied Nutrition | Food Composition, Standards, Labeling and Econ |
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