FDA Inspection
A- Z Essential Pharmaceutical, Inc.A- Z Essential Pharmaceutical, Inc. – FDA Inspection, Oct 17, 2019
Record Details
This FDA Inspection record concerns A- Z Essential Pharmaceutical, Inc., with an inspection on October 17, 2019, issued by the Center for Food Safety and Applied Nutrition, covering food/cosmetics.
- Inspection Date
- October 17, 2019
- Product Type
- Food/cosmetics
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ID · 6eaa4cd2-9a27-44f2-9fb7-6948915685da
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1106964
- FDA center
- Foods & Cosmetics
- Project area
- Food Composition, Standards, Labeling and Econ
- Enforcement
- Warning Letter
FDA Citations
12- 21 CFR 111.70(b)(1)Specifications - component identity
- 21 CFR 111.70(b)(2)Specifications-component purity, strength, composition
- 21 CFR 111.70(d)Specifications - labels, packaging
- 21 CFR 111.70(e)Specifications - identity, purity, strength, composition
- 21 CFR 111.27(d)Equipment - maintain - general
- 21 CFR 111.35(b)(2)Document-equipment date of use, maintain, clean, sanitize
- 21 CFR 111.255(b)Batch record - complete
- 21 CFR 111.205(b)(1)Master manufacturing record - specifications; quality
- 21 CFR 111.123(a)(5)Quality control operations - reprocessing
- 21 CFR 111.105(a)Quality control - processes, specifications, written procedures
Showing 10 of 12 citations.
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Other FDA inspections of A- Z Essential Pharmaceutical, Inc.
3| Date | Classification | Office | Project area |
|---|---|---|---|
| September 16, 2026 | VAI | Los Angeles District Office | Food Composition, Standards, Labeling and Econ |
| October 19, 2021 | VAI | Center for Food Safety and Applied Nutrition | Food Composition, Standards, Labeling and Econ |
| June 7, 2016 | NAI | Center for Food Safety and Applied Nutrition | Foodborne Biological Hazards |
Other documents for A- Z Essential Pharmaceutical, Inc.
- FDA Inspection 1336076 - 2026-09-16
- FDA Inspection 1155221 - 2021-10-19
- FDA Inspection 978791 - 2016-06-07
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