FDA Inspection
Ferngrove Pharmaceuticals Pty. Ltd.Ferngrove Pharmaceuticals Pty. Ltd. – FDA Inspection, Nov 3, 2023
Record Details
This FDA Inspection record concerns Ferngrove Pharmaceuticals Pty. Ltd., with an inspection on November 3, 2023, issued by the Center for Food Safety and Applied Nutrition, covering food/cosmetics.
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ID · a425d286-0280-489f-990c-caf41f3da4a7
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1221864
- FDA center
- Foods & Cosmetics
- Project area
- Food Composition, Standards, Labeling and Econ
- Outcome
- Form 483 issued
FDA Citations
15- 21 CFR 111.70(b)(1)Specifications - component identity
- 21 CFR 111.70(b)(2)Specifications-component purity, strength, composition
- 21 CFR 111.70(b)(3)Specifications - contamination limits
- 21 CFR 111.70(e)Specifications - contamination limits
- 21 CFR 111.70(e)Specifications - identity, purity, strength, composition
- 21 CFR 111.303Written procedures - tests, examinations; specifications met
- 21 CFR 111.205(a)Master manufacturing record - each batch
- 21 CFR 111.255(b)Batch record - complete
- 21 CFR 111.205(a)Master manufacturing record - each batch
- 21 CFR 111.255(b)Batch record - complete
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