550749

Advantage Dose Llc — FEI 3006586297

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
November 12, 2008
Fiscal Year
2009
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Shreveport, LA (United States)

Citations

IDCFRDescription
104921 CFR 211.22(a)Approve or reject components, products
109821 CFR 211.22(c)Approve or reject procedures or specs
113321 CFR 211.25(a)GMP Training Frequency
116221 CFR 211.28(a)Protective Apparel Not Worn
116321 CFR 211.28(b)Habits of good sanitation & health
121321 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
127421 CFR 211.68(a)Calibration/Inspection/Checking not done
139521 CFR 211.103Actual vs. theoretical yields not determined
144821 CFR 211.111Establishment of time limitations
145021 CFR 211.113(a)Procedures for non-sterile drug products
145421 CFR 211.115(a)Reprocessing procedures not written or followed
154021 CFR 211.125(a)Strict control not exercised over labeling issued
162921 CFR 211.130(a)Prevention of cross contamination, mix-ups
176721 CFR 211.137(a)Expiration date lacking
178721 CFR 211.80(a)Procedures To Be in Writing
186821 CFR 211.94(b)Protection from external factors
188321 CFR 211.165(a)Testing and release for distribution
188521 CFR 211.165(b)Microbiological testing
189321 CFR 211.165(f)Reprocessed drug products not meeting acceptance criteria
191421 CFR 211.166(a)Lack of written stability program
192721 CFR 211.166(b)Accelerated stability studies
200121 CFR 211.184(b)Component Test Records
200821 CFR 211.186(a)Written procedures followed
354821 CFR 211.46(c)Air filtration system lacking in production area
354921 CFR 211.46(c)Air recirculation of dust from production areas
355021 CFR 211.46(c)Exhaust systems inadequate to control air contamination
355921 CFR 211.56(a)Sanitation--buildings not clean, free of infestation
356221 CFR 211.56(c)Written procedures lacking for use of pesticides etc.
356521 CFR 211.58Buildings not maintained in good state of repair
357021 CFR 211.100(a)Approval and review of procedures
357121 CFR 211.100(a)Changes to Procedures Not Reviewed, Approved
358221 CFR 211.105(a)Identification of containers, lines, equipment
358521 CFR 211.110(a)Control procedures to monitor and validate performance
363221 CFR 211.170(b)Annual visual exams of drug products
433621 CFR 211.150Written distribution procedure
434221 CFR 211.142(b)Storage under appropriate conditions
436021 CFR 211.170(b)Reserve drug product sample quantity - all tests
437221 CFR 211.188(b)(8)Labeling control records including specimens or copies
437321 CFR 211.188(b)(7)Actual yield, % of theoretical yield
438721 CFR 211.198(a)Reporting of adverse drug experience to FDA
439121 CFR 211.180(e)(2)Items to cover on annual reviews