FDA Inspection
Life HMELife HME – FDA Inspection, Sep 11, 2015
Record Details
This FDA Inspection record concerns Life HME, with an inspection on September 11, 2015, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Life HME
- Inspection Date
- September 11, 2015
- Product Type
- Drugs
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ID · 428b7186-e1c8-49bf-b190-84fb98a7722e
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 944976
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
4- 21 CFR 211.150(a)Distribution of oldest stock first
- 21 CFR 211.25(a)Training--operations, GMPs, written procedures
- 21 CFR 211.142Written warehousing procedures established/followed
- 21 CFR 211.22(a)Lack of quality control unit
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