FDA Inspection
Penn Herb Company, Ltd.Penn Herb Company, Ltd. – FDA Inspection, Jun 13, 2024
Record Details
This FDA Inspection record concerns Penn Herb Company, Ltd., with an inspection on June 13, 2024, issued by the Center for Food Safety and Applied Nutrition, covering food/cosmetics.
- People
- Alan D. Centi (Investigator)
- Siobhan G. Taylor (Issuing Officer)
- Xinyi Hui (Issuing Officer)
- Yessika Mashinski (Issuing Officer)
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ID · 945810df-1242-40dc-85bf-f26c75baa787
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1241018
- FDA center
- Foods & Cosmetics
- Project area
- Food Composition, Standards, Labeling and Econ
FDA Citations
26- 21 CFR 111.27(b)Instruments - calibration
- 21 CFR 111.30(b)Equipment - automated - suitability
- 21 CFR 111.27(d)(1)Equipment - taken apart
- 21 CFR 111.113(a)(1)Quality control production, process control; material review, disposition
- 21 CFR 111.70(e)Specifications - identity, purity, strength, composition
- 21 CFR 111.70(b)(3)Specifications - contamination limits
- 21 CFR 111.12Personnel - quality control personnel - qualified
- 21 CFR 111.27(a)(7)Compressed air, gases
- 21 CFR 111.123(a)(1)Quality control operations - master manufacturing record, modifications
- 21 CFR 111.255(b)Batch record - complete
Showing 10 of 26 citations.
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Other FDA inspections of Penn Herb Company, Ltd.
5| Date | Classification | Office | Project area |
|---|---|---|---|
| June 8, 2026 | Not classified | Philadelphia District Office | Foodborne Biological Hazards |
| June 21, 2019 | VAI | Center for Food Safety and Applied Nutrition | Food Composition, Standards, Labeling and Econ |
| August 21, 2015 | NAI | Center for Food Safety and Applied Nutrition | Food Composition, Standards, Labeling and Econ |
| August 28, 2013 | VAI | Center for Food Safety and Applied Nutrition | Food Composition, Standards, Labeling and Econ |
| June 11, 2009 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Penn Herb Company, Ltd.
- FDA Inspection 1320900 - 2026-06-08
- FDA Inspection 1094363 - 2019-06-21
- FDA Inspection 939190 - 2015-08-21
- FDA Inspection 846704 - 2013-08-28
- FDA Inspection 589992 - 2009-06-11
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