FDA Inspection
Madison One Acme IncMadison One Acme Inc – FDA Inspection, Mar 21, 2017
Record Details
This FDA Inspection record concerns Madison One Acme Inc, with an inspection on March 21, 2017, issued by the Center for Food Safety and Applied Nutrition, covering food/cosmetics.
- People
- Ling-Yu L. Liu (Issuing Officer)
- Nicholas J. Lahey (Issuing Officer)
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ID · d29d6c6d-54de-4f39-9c35-5ed91c4c96eb
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1004956
- FDA center
- Foods & Cosmetics
- Project area
- Food Composition, Standards, Labeling and Econ
- Outcome
- Form 483 issued
FDA Citations
8- 21 CFR 111.123Quality control operations - master, batch, manufacturing
- 21 CFR 111.205(c)Master manufacturing record: readily available
- 21 CFR 111.70(b)(1)Specifications - component identity
- 21 CFR 111.70(b)(2)Specifications-component purity, strength, composition
- 21 CFR 111.70(e)Specifications - contamination limits
- 21 CFR 111.70(e)Specifications - identity, purity, strength, composition
- 21 CFR 111.75(a)(2)Appropriate tests, examinations; certificate of analysis
- 21 CFR 111.75(c)(2)Specifications met - test, examinations; compliance
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Other FDA inspections of Madison One Acme Inc
3| Date | Classification | Office | Project area |
|---|---|---|---|
| May 13, 2019 | VAI | Center for Food Safety and Applied Nutrition | Food Composition, Standards, Labeling and Econ |
| October 2, 2015 | NAI | Center for Food Safety and Applied Nutrition | Food Composition, Standards, Labeling and Econ |
| February 4, 2010 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Madison One Acme Inc
- FDA Inspection 1089405 - 2019-05-13
- FDA Inspection 943037 - 2015-10-02
- FDA Inspection 643476 - 2010-02-04
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