FDA Inspection
AJES Pharmaceuticals, LLCAJES Pharmaceuticals, LLC – FDA Inspection, Jul 18, 2014
Record Details
This FDA Inspection record concerns AJES Pharmaceuticals, LLC, with an inspection on July 18, 2014, issued by the Center for Food Safety and Applied Nutrition, covering food/cosmetics.
- Company
- AJES Pharmaceuticals, LLC
- Inspection Date
- July 18, 2014
- Product Type
- Food/cosmetics
View Company Profile
ID · 80376cca-c7f5-44a5-9e9d-f74d7094e36e
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 888236
- FDA center
- Foods & Cosmetics
- Project area
- Food Composition, Standards, Labeling and Econ
FDA Citations
8- 21 CFR 111.560(a)(2)Product complaint - quality control investigate
- No AE report made (dietary supplement)
- 21 CFR 111.75(a)(1)(i)Component - verify identity, dietary ingredient
- 21 CFR 111.360Manufacturing operations - sanitation
- 21 CFR 111.73Specifications met - identity, purity, strength, composition
- 21 CFR 111.320(b)Examination, testing; scientifically valid
- 21 CFR 111.260(l)(4)Batch record - approved, released, rejected
- 21 CFR 111.35(b)(3)Instruments, controls; calibrate date, reference std, method
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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