FDA Inspection
Advantage Dose LlcAdvantage Dose Llc – FDA Inspection, Nov 12, 2008
Record Details
This FDA Inspection record concerns Advantage Dose Llc, with an inspection on November 12, 2008, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Advantage Dose Llc
- Inspection Date
- November 12, 2008
- Product Type
- Drugs
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ID · d3271bf6-b049-492b-a580-ae02deeff4e1
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 550749
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
41- 21 CFR 211.166(b)Accelerated stability studies
- 21 CFR 211.103Actual vs. theoretical yields not determined
- 21 CFR 211.46(c)Exhaust systems inadequate to control air contamination
- 21 CFR 211.46(c)Air recirculation of dust from production areas
- 21 CFR 211.105(a)Identification of containers, lines, equipment
- 21 CFR 211.188(b)(8)Labeling control records including specimens or copies
- 21 CFR 211.56(a)Sanitation--buildings not clean, free of infestation
- 21 CFR 211.58Buildings not maintained in good state of repair
- 21 CFR 211.100(a)Changes to Procedures Not Reviewed, Approved
- 21 CFR 211.94(b)Protection from external factors
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