FDA Inspection
GnuPharma Corp.GnuPharma Corp. – FDA Inspection, Apr 13, 2017
Record Details
This FDA Inspection record concerns GnuPharma Corp., with an inspection on April 13, 2017, issued by the Dallas District Office, covering foods & cosmetics.
- Office
- Dallas District Office
- People
- Jonathan M. Mcbride (Issuing Officer)
- Rian L. Pope (Company Rep)
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ID · bc655e28-8908-4861-8f06-7c6b75cd5ee5
Inspection Facts
- Inspection number
- 1008369
- FDA center
- Foods & Cosmetics
- Project area
- Food Composition, Standards, Labeling and Econ
- Outcome
- Form 483 issued
FDA Citations
10- 21 CFR 111.140(b)(1)Records - quality control operations; responsibilities
- 21 CFR 111.16Written procedures - cleaning
- 21 CFR 111.205(a)Master manufacturing record - unique formulation
- 21 CFR 111.255(a)Batch record - every batch
- 21 CFR 111.25(b)Procedures - calibrating automated, mechanical equip
- 21 CFR 111.503Written procedures - returned dietary supplement
- 21 CFR 111.55Production, process controls - implement
- 21 CFR 111.553Written procedures - product complaint
- 21 CFR 111.75(a)(1)(i)Component - verify identity, dietary ingredient
- 21 CFR 111.75(a)(2)(ii)(A)Component - qualify supplier
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Other FDA inspections of GnuPharma Corp.
2| Date | Classification | Office | Project area |
|---|---|---|---|
| June 16, 2022 | VAI | Center for Food Safety and Applied Nutrition | Food Composition, Standards, Labeling and Econ |
| May 31, 2018 | NAI | Center for Food Safety and Applied Nutrition | Food Composition, Standards, Labeling and Econ |
Other documents for GnuPharma Corp.
- FDA Inspection 1171997 - 2022-06-16
- FDA Inspection 1074035 - 2018-05-31
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