FDA Inspection
Pine Creek General StorePine Creek General Store – FDA Inspection, Nov 13, 2017
Record Details
This FDA Inspection record concerns Pine Creek General Store, with an inspection on November 13, 2017, issued by the Center for Food Safety and Applied Nutrition, covering food/cosmetics.
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ID · db569818-c293-46d3-8aa1-44757d38f54c
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1031687
- FDA center
- Foods & Cosmetics
- Project area
- Food Composition, Standards, Labeling and Econ
- Outcome
- Form 483 issued
FDA Citations
10- 21 CFR 111.75(a)(1)(i)Component - verify identity, dietary ingredient
- 21 CFR 111.453Written procedures - holding
- 21 CFR 111.70(e)Specifications - identity, purity, strength, composition
- 21 CFR 111.403Written procedures - labeling operations
- 21 CFR 111.553Written procedures - product complaint
- 21 CFR 111.503Written procedures - returned dietary supplement
- 21 CFR 111.65Quality control - quality, dietary supplement
- 21 CFR 111.255(a)Batch record - every batch
- 21 CFR 111.205(a)Master manufacturing record - unique formulation
- 21 CFR 111.83(b)(3)Reserve sample - retained
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