Document dQ4Q7nR8Xg4RmMVDRdMbgLQ4Q

, OA diJOlOXIj .AdO-, ^owaxj Circular Bulletin To: All Works - Plant Managers & Superintendents All Sales Offices dept. Quality Section date May 8, 1963 no. 214 Subject: USP - NF PRODUCTS FEDERAL FOOD, DRUG & COSMETIC ACT REGISTRATION OF PLANTS , 1, Recent amendments to subject act have made mandatory the | registration of all locations handling drugs. USP and NF products which are manufactured, repackaged, or relabeled i are classified as falling within the scope of the act. i , Each registered location will be subject to Inspection by a Food and Drug Official at least once every two years. Locations now registered are; Bay Point f B&A Calumet ; Delaware ; El Segundo j 2. Locations, other than those registered, must advise this office If they contemplate manufacturing, repackaging, or relabeling USP or NF products. 3* Sales Is also requested to advise If handling of USP or NF products Is planned for locations other than those registered. 4. When a Food and Drug Official visits a location, the same pro cedures must be followed as outlined In Mr. French's Circular Bulletin No. 10 pertaining to Labeling of Hazardous substances. 5* Those locations now subject to Inspection are cautioned to take all possible care to prevent contamination of the product which might occur In processing, handling, and as a result of poor housekeeping. Sampling and testing frequencies must be reviewed to Insure representative samples and analyses are ob tained. i \ CMM:SK cc: Mtn, Vice Pres., Mr. J. S. Brown Mtn, Sales Managers Mtn, Product Managers Mtn, Gen'l Supvr of Stations, Mr. J. L. Davis Jacksonville Works, Oen'l Supt., Mr. J. D. Sundy I i t 4 Menasha Works, Frodn Supv., Mr. C. E. Ploudre x i SUGGESTED RETENTION * C] Dtotroy Aftor Noting j Dottroy Aftor Complying ^Dottroy A {tor l~Xl rotatn Indefinitely 1"1 Rotnrn With Commtnt* ASI 00002347