FDA Inspection
Crossing Cultures LLC DBA Goddess GardenCrossing Cultures LLC DBA Goddess Garden – FDA Inspection, Nov 4, 2016
Record Details
This FDA Inspection record concerns Crossing Cultures LLC DBA Goddess Garden, with an inspection on November 4, 2016, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · 8714875d-a1d8-470c-8f3f-243eb1dd8814
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1012927
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
7- 21 CFR 211.22(b)Adequate lab facilities not available
- 21 CFR 211.100(a)Changes to Procedures Not Reviewed, Approved
- 21 CFR 211.165(f)Failing drug products not rejected
- 21 CFR 211.166(a)Written program not followed
- 21 CFR 211.180(e)(1)Review of representative number of batches
- 21 CFR 211.192No written record of investigation
- 21 CFR 211.192Written record of investigation incomplete
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