Garry N Sun USA,Inc. FDA Inspection Record
Garry N Sun USA,Inc. is an FDA-inspected facility (FEI 3003299635) located in Reno, NV, US. RegDataLab tracks 3 FDA inspections at this facility.
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What FDA found at this site
- Latest inspection
- Apr 25, 2025: Voluntary Action Indicated (VAI)
- Inspections on record
- 3 (3 VAI)
- Last OAI inspection
- None on record
- Warning letters
- None matched to this FEI. Many letters do not state an FEI: search warning letters by company name
- Recalls as the recalling firm
- 1, latest May 17, 2021
Inspections and what FDA cited
| Date | Result | What FDA cited |
|---|---|---|
| Apr 25, 2025 | Voluntary Action Indicated (VAI) | Specifications - finished packaging, labeling (21 CFR 111.70(g)) Component - confirm identity; specifications met (21 CFR 111.75(a)(2)) Appropriate tests, examinations; certificate of analysis (21 CFR 111.75(a)(2)) Specifications - components (21 CFR 111.70(b)) and 5 more |
| Jul 11, 2017 | Voluntary Action Indicated (VAI) | Equipment - procedures (21 CFR 111.25) Procedures - calibrating instruments (21 CFR 111.25(a)) Procedures - equipment - cleaning, sanitizing (21 CFR 111.25(c)) Batch record - approved, released, rejected (21 CFR 111.260(l)(4)) and 8 more |
| Feb 16, 2012 | Voluntary Action Indicated (VAI) | Written procedures - holding (21 CFR 111.453) Written procedures - product complaint (21 CFR 111.553) Written procedures - returned dietary supplement (21 CFR 111.503) |
Recalls
| Date | Class | Recall | Product and reason |
|---|---|---|---|
| May 17, 2021 | Class I | F-0633-2021 | Mahayograj Guggulu;
120 Vegetarian Capsules, 1/2 lb. bags of powder
Dietary… State of Iowa collected consumer sample and found high levels of lead - 12,200 mg/kg |
Facility details
- Company
- Garry N Sun USA,Inc.
- Location
- Reno, NV (US)
- Source
- inspections