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Packaging Device and or shipping containers are not designed constructed to protect the from alteration damage during processing storage handling distribution. Master production and control records lack description of the drug containers closures packaging materials specimen copy each label all other labeling signatures dates entered by person persons responsible fo CFR. d Testing Each Component for Conformity with Specs is not tested all appropriate written specifications purity strength and quality. f Container sample results Your indicated that more than one exceeded bacteria per milliliter of capacity colony square centimeter surface area the presence coliform organisms. k Batch recordpackaging labeling Your production records did not include documentation the time of performance operations. b Physical plantrepair You did not maintain your sufficient to prevent components dietary supplements or contact surfaces from becoming contaminated | Guidance for Industry - U S Food and Drug Administration ...

B Batch recorddate time maintenance Your production records did not include the identity of equipment and processing lines used producing . Department of Health and Human Services

A Examination testing appropriate You did not verify that the laboratory and methodologies are for their intended use. b You did not calibrate instruments or controls used manufacturing testing component dietary supplement before the first frequency specified writing by manufacturer routine intervals as necessary to ensure accur CFR. Biological product deviation report Failure to submit within days from the date you acquired information suggesting that reportable event occurred. Distribution Record Requirements records do not contain the name and strength of drug product description dosage form address consignee date quantity shipped lot control number . c Kits not FDA approved specifically labeled Communicable disease agent tests were FDAlicensed or cleared donor screening for cadaveric specimens when such was available and used CFR

FDAGMP Good Manufacturing Practice SOPhttps www cm ml cfr . Reprocessed returned drug products were without assuring that the subsequent met appropriate standards of safety identity strength quality purity. c Official review You did not make available for and copying at reasonable times all records plans procedures required by the regulations. Blue Rose Ind. Written warehousing procedures established followed describing the of drug products not . c Children as subjects The IRB approved conduct of research involving but did not determine that was compliance with CFR Subpart . b Physical plantspace equipment materials Your did not have adequate for the orderly placement of and holding as necessary maintenance cleaning sanitizing operations to prevent contamination mixups components dietary supplements CFR. a Documentation Process validation activities results have not been documented approved adequately . Written records kept in individual logs of major equipment cleaning maintenance use are not included . b Adequate ventilation Failure to provide control equipment minimize odors and vapors areas where they may contaminate food. a Rx not followed Failure to your veterinarian s prescription for dosage frequency and duration of treatment route administration species class animal preslaughter withdrawal time special cautionary directions. a Written program not followed The stability testing is