FDA Inspection
Xela Pack, IncXela Pack, Inc – FDA Inspection, Oct 15, 2010
Record Details
This FDA Inspection record concerns Xela Pack, Inc, with an inspection on October 15, 2010, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Xela Pack, Inc
- Inspection Date
- October 15, 2010
- Product Type
- Drugs
View Company Profile
ID · e50b9c5e-7496-4d63-a2da-b42d2db6057f
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 696962
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
5- 21 CFR 211.125(f)Procedures Written and Followed
- 21 CFR 211.80(a)Procedures To Be in Writing
- 21 CFR 211.67(b)Written procedures not established/followed
- 21 CFR 111.553Written procedures - product complaint
- 21 CFR 123.6(b)No HACCP plan
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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 |
| March 1, 2013 | VAI | Center for Food Safety and Applied Nutrition | Colors and Cosmetics Technology |
| January 24, 2012 | VAI | Center for Food Safety and Applied Nutrition | Food Composition, Standards, Labeling and Econ |
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 820583 - 2013-03-01
- FDA Inspection 764320 - 2012-01-24
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