FDA Inspection
AJES Pharmaceuticals, LLCAJES Pharmaceuticals, LLC – FDA Inspection, Mar 9, 2016
Record Details
This FDA Inspection record concerns AJES Pharmaceuticals, LLC, with an inspection on March 9, 2016, issued by the Center for Food Safety and Applied Nutrition, covering food/cosmetics.
- Company
- AJES Pharmaceuticals, LLC
- Inspection Date
- March 9, 2016
- Product Type
- Food/cosmetics
View Company Profile
ID · 85649561-faae-4c11-9e22-d80abd79bdf6
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 962200
- FDA center
- Foods & Cosmetics
- Project area
- Food Composition, Standards, Labeling and Econ
FDA Citations
6- No label copy submitted with AE report (dietary supplement)
- 21 CFR 111.75(a)(1)(i)Component - verify identity, dietary ingredient
- 21 CFR 111.73Specifications met - identity, purity, strength, composition
- 21 CFR 111.605Records - keep: 1 year, 2 years
- 21 CFR 111.83(b)(3)Reserve sample - retained
- 21 CFR 111.20(c)(3)Physical plant - separate areas for products
Full citation text and observation details available on the Dashboard.
Other FDA inspections of AJES Pharmaceuticals, LLC
8| Date | Classification | Office | Project area |
|---|---|---|---|
| February 7, 2025 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| December 9, 2024 | VAI | New York District Office | Food Composition, Standards, Labeling, and Economics |
| November 21, 2022 | VAI | Center for Food Safety and Applied Nutrition | Food Composition, Standards, Labeling and Econ |
| October 14, 2021 | NAI | Center for Food Safety and Applied Nutrition | Foodborne Biological Hazards |
| March 29, 2018 | VAI | Center for Food Safety and Applied Nutrition | Food Composition, Standards, Labeling and Econ |
Other documents for AJES Pharmaceuticals, LLC
- FDA Inspection 1262754 - 2025-02-07
- FDA Inspection 1253074 - 2024-12-09
- FDA Inspection 1191048 - 2022-11-21
- FDA Inspection 1155111 - 2021-10-14
- FDA Inspection 1046683 - 2018-03-29
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