FDA Inspection
Xela Pack, IncXela Pack, Inc – FDA Inspection, Mar 1, 2013
Record Details
This FDA Inspection record concerns Xela Pack, Inc, with an inspection on March 1, 2013, issued by the Center for Food Safety and Applied Nutrition, covering food/cosmetics.
- Company
- Xela Pack, Inc
- Inspection Date
- March 1, 2013
- Product Type
- Food/cosmetics
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ID · ea88f508-81af-4552-8008-4336a59b8ac8
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 820583
- FDA center
- Foods & Cosmetics
- Project area
- Colors and Cosmetics Technology
FDA Citations
18- 21 CFR 211.100(b)Procedure Deviations Recorded and Justified
- 21 CFR 211.186(b)(9)Complete instructions, procedures, specifications et. al.
- 21 CFR 123.10HACCP training or qualification
- 21 CFR 211.125(f)Procedures Written and Followed
- 21 CFR 211.188(b)(8)Labeling Control Records and Label Copies
- 21 CFR 211.80(a)Procedures To Be in Writing
- 21 CFR 211.67(b)Written procedures not established/followed
- 21 CFR 120.24(c)Process controls - not exempt, single facility
- 21 CFR 120.8(b)(1)HACCP plan - food hazards not listed
- 21 CFR 123.6(c)(2)Critical control points
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Other FDA inspections of Xela Pack, Inc
6| Date | Classification | Office | Project area |
|---|---|---|---|
| February 9, 2023 | Not classified | Detroit District Office | |
| February 7, 2019 | NAI | Center for Food Safety and Applied Nutrition | Foodborne Biological Hazards |
| December 22, 2015 | VAI | Center for Food Safety and Applied Nutrition | Foodborne Biological Hazards |
| January 24, 2012 | VAI | Center for Food Safety and Applied Nutrition | Food Composition, Standards, Labeling and Econ |
| October 15, 2010 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Xela Pack, Inc
- FDA Inspection 1197487 - 2023-02-09
- FDA Inspection 1079243 - 2019-02-07
- FDA Inspection 961854 - 2015-12-22
- FDA Inspection 764320 - 2012-01-24
- FDA Inspection 696962 - 2010-10-15
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