FDA Inspection
Baby Your BottomBaby Your Bottom – FDA Inspection, Oct 27, 2009
Record Details
This FDA Inspection record concerns Baby Your Bottom, with an inspection on October 27, 2009, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Baby Your Bottom
- Inspection Date
- October 27, 2009
- Product Type
- Drugs
View Company Profile
ID · 9a19eb19-b317-49d2-8c21-baba0474cdea
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 624847
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
10- 21 CFR 211.150(b)Recall facilitation
- 21 CFR 211.137(d)Expiration date location on labeling
- 21 CFR 211.142(a)Quarantine - actual practice
- 21 CFR 211.25(a)Training , Education , Experience overall
- 21 CFR 211.125(f)Procedures Written and Followed
- 21 CFR 211.198(a)Complaint Handling Procedure
- 21 CFR 211.142Written warehousing procedures established/followed
- 21 CFR 211.22(a)Lack of quality control unit
- 21 CFR 211.150Written distribution procedure
- 21 CFR 211.142(a)Quarantine - written procedures
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