FDA Inspection
P & G K.K. (Procter & Gamble)P & G K.K. (Procter & Gamble) – FDA Inspection, Dec 11, 2015
Record Details
This FDA Inspection record concerns P & G K.K. (Procter & Gamble), with an inspection on December 11, 2015, issued by the Center for Drug Evaluation and Research, covering drugs.
- Inspection Date
- December 11, 2015
- Product Type
- Drugs
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ID · 764c6c41-f9c7-4a31-877a-6a8b52b5b1a1
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 954584
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
7- 21 CFR 211.110(a)Control procedures to monitor and validate performance
- 21 CFR 211.160(a)Following/documenting laboratory controls
- 21 CFR 211.67(c)Cleaning/maintenance records not kept
- 21 CFR 211.84(b)Representative Samples
- 21 CFR 211.188(b)Batch production and Batch Control Record Requirements
- 21 CFR 211.188(b)(2)Identification of Equipment and Lines
- 21 CFR 211.22(d)Procedures not in writing, fully followed
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