FDA Inspection
Investors Ltd dba SCM Life OxygenInvestors Ltd dba SCM Life Oxygen – FDA Inspection, Sep 20, 2010
Record Details
This FDA Inspection record concerns Investors Ltd dba SCM Life Oxygen, with an inspection on September 20, 2010, issued by the Center for Drug Evaluation and Research, covering drugs.
- Inspection Date
- September 20, 2010
- Product Type
- Drugs
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ID · cea3ca11-21f9-4c8b-af69-ca71b840301e
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 680555
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
8- 21 CFR 211.101(b)Measured components for manufacturing
- 21 CFR 211.25(a)Training , Education , Experience overall
- 21 CFR 211.194(a)(8)Second person sign off
- 21 CFR 211.134(a)Correct labels during finishing operations
- 21 CFR 211.160(b)(4)Establishment of calibration procedures
- 21 CFR 211.125(a)Strict control not exercised over labeling issued
- 21 CFR 211.130(c)Lot or control number assigned
- 21 CFR 211.80(a)Written Procedures Not Followed
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