FDA Inspection
Uckele Health & Nutrition, Inc.Uckele Health & Nutrition, Inc. – FDA Inspection, Sep 22, 2017
Record Details
This FDA Inspection record concerns Uckele Health & Nutrition, Inc., with an inspection on September 22, 2017, issued by the Center for Food Safety and Applied Nutrition, covering food/cosmetics.
- People
- Jacob A. Clark (Issuing Officer)
- Martin R. Vowell (Investigator)
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ID · 12db7eeb-cea6-4200-b4b0-c1e12c1530e5
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1026419
- FDA center
- Foods & Cosmetics
- Project area
- Food Composition, Standards, Labeling and Econ
- Outcome
- Form 483 issued
FDA Citations
9- 21 CFR 111.120(b)Quality control operations - specifications; components, packaging, labels
- 21 CFR 111.123(b)(1)Quality control - components, identity specifications
- 21 CFR 111.205(a)Master manufacturing record - unique formulation
- 21 CFR 111.255(a)Batch record - every batch
- 21 CFR 111.260(f)Batch record - yield
- 21 CFR 111.260(g)Batch record - results; monitoring
- 21 CFR 111.260(j)(2)(ii)Batch record - initials; verifying weight
- 21 CFR 111.570(b)(2)(ii)(F)Record - product complaint; findings
- 21 CFR 111.70(e)Specifications - identity, purity, strength, composition
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Other FDA inspections of Uckele Health & Nutrition, Inc.
6| Date | Classification | Office | Project area |
|---|---|---|---|
| October 31, 2024 | VAI | Detroit District Office | Monitoring of Marketed Animal Drugs, Feeds, and Devices |
| April 15, 2019 | NAI | Center for Veterinary Medicine | Monitoring of Marketed Animal Drugs, Feed, and Devices |
| July 6, 2016 | NAI | Center for Veterinary Medicine | Monitoring of Marketed Animal Drugs, Feed, and Devices |
| August 4, 2015 | OAI | Center for Food Safety and Applied Nutrition | Food Composition, Standards, Labeling and Econ |
| February 17, 2015 | NAI | Center for Veterinary Medicine | Monitoring of Marketed Animal Drugs, Feed, and Devices |
Other documents for Uckele Health & Nutrition, Inc.
- FDA Inspection 1253000 - 2024-10-31
- FDA Inspection 1089784 - 2019-04-15
- FDA Inspection 977579 - 2016-07-06
- FDA Inspection 936894 - 2015-08-04
- FDA Inspection 914529 - 2015-02-17
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