FDA Inspection
Global Source Management & Consulting, IncFDA Inspection 771283 - Global Source Management & Consulting, Inc - March 15, 2012
Record Details
This FDA Inspection record concerns Global Source Management & Consulting, Inc, with an inspection on March 15, 2012, issued by the Center for Drug Evaluation and Research, covering drugs.
- Inspection Date
- March 15, 2012
- Product Type
- Drugs
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ID · 48a46e3a-8cae-4d70-9e04-1f8b0ee050a1
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 771283
- FDA center
- Human Drugs
- Project area
- Unapproved and Misbranded Drugs
FDA Citations
10- 21 CFR 111.83(a)Reserve sample - collect, hold
- 21 CFR 111.70(e)Specifications - identity, purity, strength, composition
- 21 CFR 111.103Written procedures - quality control operations
- 21 CFR 111.553Written procedures - product complaint
- 21 CFR 111.95(b)(2)Documentation - supplier qualification
- 21 CFR 111.205(a)Master manufacturing record - unique formulation
- 21 CFR 111.20(f)Physical plant - bulbs, fixtures, skylights
- 21 CFR 111.255(b)Batch record - complete
- 21 CFR 111.20(d)(1)(i)Floors, walls, ceilings
- 21 CFR 111.20(h)Physical plant - screening against pests
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Other FDA inspections of Global Source Management & Consulting, Inc
1| Date | Classification | Office | Project area |
|---|---|---|---|
| August 20, 2013 | OAI | Center for Food Safety and Applied Nutrition | Food Composition, Standards, Labeling and Econ |
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