FDA Inspection
Hi-Tech Nutraceuticals LLCHi-Tech Nutraceuticals LLC – FDA Inspection, Feb 24, 2023
Record Details
This FDA Inspection record concerns Hi-Tech Nutraceuticals LLC, with an inspection on February 24, 2023, issued by the Philadelphia District Office.
- Company
- Hi-Tech Nutraceuticals LLC
- Inspection Date
- February 24, 2023
View Company Profile
ID · 517344ba-a872-4c6d-a7bb-c183068ae3b8
Inspection Facts
- Inspection number
- 1198272
- FDA center
- Foods & Cosmetics
- Outcome
- Form 483 issued
FDA Citations
12- 21 CFR 111.103Written procedure quality control operations material review
- 21 CFR 111.10(b)Personnel - hygienic practices
- 21 CFR 111.123(a)(2)Quality control operations - batch production records
- 21 CFR 111.123(a)(7)Quality control operations - finished batch, specifications
- 21 CFR 111.153Written procedures - components
- 21 CFR 111.205(b)(1)Master manufacturing record - specifications; quality
- 21 CFR 111.27(a)(3)(v)Equipment - protect from contamination
- 21 CFR 111.27(a)(7)Compressed air, gases
- 21 CFR 111.27(d)(7)Utensils - store
- 21 CFR 111.360Manufacturing operations - sanitation
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Other FDA inspections of Hi-Tech Nutraceuticals LLC
4| Date | Classification | Office | Project area |
|---|---|---|---|
| September 5, 2019 | Not classified | Philadelphia District Office | |
| July 8, 2014 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| November 20, 2012 | VAI | Center for Food Safety and Applied Nutrition | Food Composition, Standards, Labeling and Econ |
| October 26, 2010 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Hi-Tech Nutraceuticals LLC
- FDA Inspection 1101529 - 2019-09-05
- FDA Inspection 886522 - 2014-07-08
- FDA Inspection 807526 - 2012-11-20
- FDA Inspection 696642 - 2010-10-26
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