author: united states food and drug administration

FDA Inspections Operations Manual: For Drugs, Devices, & Cosmetics

... space is inadequate , continue on a FDA - 464a , " C / R CONTINUATION SHEET ... below , if only one person is involved in the sample collection . The numbered captions below match ... Code . Assignments and Compliance Programs will bear a ...

FDA/ORA International Inspection Manual and Travel Guide

... code Central File Number ( CFN ) : Q 3 4 5 6 7 96345 Establishment Name and Address ( Sufficient to verify or locate Central File No. ) : Sam's Biotech : 1213 avenue 10 Fereign City , Foreign ( 123 ) 456-7890 Establishment Phone Number ...

Pesticide analytical manual

... L - shape to fit tank ( 2 ) above . ( 6 ) Mounting board . Cut 2 pieces , 12-1 / 4 " x 8-3 / 4 " from desk blotter Desaga / Brinkman standard model , or equiv . ( 7 ) Pipets , spotting . — 1 μl ( Kontes Glass Co. , Cat . No. K - 422520 ) ...

Safety of Large Volume Parenteral Solutions: National Symposium Proceedings

... solutions are a formidable health hazard , if the contamination is bacterial , and a hazard of un- known degree if the contamination is mold . Our state of knowledge regarding the pathogenicity of intravenously injected molds is no ...

Selected Technical Publications

... AMPHETAMINE ISOMERIC COMPOSITION 0 % 100 % FIG . 1 - Percentage of benzoyl ... salt to separatory funnel with pledget of glass wool in stem . Add 20 ml water ... Make aqueous solution basic with 10 % NaOH . Shake fun- nel 1 min , let ...

Notices of Judgment Under the Federal Food, Drug, and Cosmetic Act ...: Drugs and devices ...

... label statement " Vit . B - 12 60 mcgm . " was false and misleading . DISPOSITION : 1-25-62 . Default ... Plex injection , at Phoenix , Ariz . SHIPPED : On 4-26-60 and 11-30-60 , from Los Angeles , Calif . , by Injectable Pharmacal Co. LABEL ...

Notices of Judgment Under the Federal Food, Drug, and Cosmetic Act. ... Drugs and Devices

... material fact and defendants are entitled to judgment as a matter of law on their motion to dismiss and for summary ... Pega Palo vine . ( F.D.C. No. 40293. S. No. 72-967 M. ) QUANTITY : 405 pliofilm pkgs . at Bountiful , Utah , in possession ...

Civil Defense Information for Food and Drug Officials

... irritating effects on personnel , as a screening or signaling smoke , or for ... statistics indicated toxic gas shells were about twice as effective as high ... possible against the population of the critical target areas in this country ...

Notices of Judgement Under the Federal Food, Drug, and Cosmetic Act ...

... Default decree of condemnation and destruction . 21783. Adulteration of olives . U. S. v . 18 Cases * * . ( F. D. C. No. 36348 . Sample ... judgment , motion to strike , and motion for judgment on the pleadings , and upon the documents filed ...

Notices of Judgment Under the Federal Food, Drug, and Cosmetic Act: Drugs and devices

... Diet Plan ( For Complete Plan Read Booklet Inside Package ) . " How ACCOMPANYING LABELING : Leaflet entitled " Larson's C.R.D. Reducing Diet Plan " ; and counter display sheet reading in part “ Overweight ? New 8 Hour Diet Takes Pounds ...

Notices of Judgment Under the Food and Drugs Act

... Packed by The Curtis Corporation Long Beach , Cal . , U. S. A. ” It was alleged in the libels that the article was misbranded in that the state- ment " Net Contents 4 Oz . , " borne on the can label , was false and misleading and ...

Medical Devices

... test would produce equivalent or better re- sults . The agency has ... ( OSHA ) standards or are resistant to impact in compliance with FDA's less ... Answer Pamphlet # 1 on Impact- Resistant Lenses , FDA Fact Sheet- Impact - Resistant ...

Selected Technical Publications

... drostanolone is completely eluted by the 150 ml . of n - heptane , androst - 4 - ene - 3,17 - dione is partially ... enanthate 14 MW UV 97.8 BDL Testosterone propionate 14 MW INH 99.8 BDL 40 Triamcinolone 14 MW UV BDL 98.4 • 1 , Aldrich ...

Food and Drug Circular No. 1-

... Bacteria . These forms are microscopic , unicellular organisms . They consist essentially of 3 forms : ( 1 ) cocci ... COMMON NAME Bacterial canker Bacterial speck SCIENTIFIC NAME Phytomonas michiganensis . Bacterium punctulans ...

Microanalysis of Food and Drug Products

United States. Food and Drug Administration. Microanalytical Division. V. USE OF THE MICROSCOPE To cover , even in a sketchy manner , the theory of the formation of the microscope image would involve pages of discussion centering around ...

Selected Technical Publications

... chart re- corder ; and a U - shaped glass column , 6 ' x 4 mm id , packed ... Hobart mixer , and from this composite , weigh a repre- sentative portion ... volume with methanol rinses through extraction flask 145 Reprinted from Journal of ...

Staff Manual Guide Transmittal No. ...

... PS 3615 , Mailing Permit Application and Customer Profile , must be completed by the FDA Mail Manager and submitted with the printing request ( HHS 26 ) or the supplemental mail contract . PS 3615 is required by the affected U.S. Post ...

Notices of Judgment Under the Federal Food, Drug, and Cosmetic Act...: Foods

... VOLUME 18 TITLE 3 - THE PRESIDENT EXECUTIVE ORDER 10434 Op OF THE 1934 ... 18- turns by that Com- coure herreining or other voluntary subject to the fondi and ... DxDSTO atality , or offense possessed incurred , or Tes Wom D & D 19 4475 ...

Pesticide Analytical Manual: Methods for individual residues

... Haas Company , Philadelphia , PA 19105 Pesticide Petition 9F2158 . Attached as Method I. Residues of the sodium salt of acifluorfen and its amine metabolite are extracted from samples by blending with acetonitrile - 1.ON HC1 ( 7 + 3 ) ...

Food and Drugs Act, Notices of Judgement: Index to Nos. 10001-20000

... Sample no . 50557 - A . ) This case was based on an interstate shipment of evaporated apple chops which were found ... Confession of judgment . Fine , $ 100 . ( F. & D. no . 33839 . Sample no . 63705 - A . ) This case was based on an ...

Notices of Judgment Under the Food and Drugs Act

... Histeen was discovered and only after the tests had shown His- teen's power time and ti again , the secret was at last released . An End To Hay Fever Torture The Chicago specialist's find may easily be considered the most basic work in ...

Food and Drugs Act, Notices of Judgement: Index to Nos. 10001-20000

... Histeen was discovered and only after the tests had shown His- teen's power time and ti again , the secret was at last released . An End To Hay Fever Torture The Chicago specialist's find may easily be considered the most basic work in ...

Notices of Judgment Under the Federal Food, Drug, and Cosmetic Act. ... Drugs and Devices

... Okra , and Celery Tablets ; Amino Acids Capsules ; Food Minerals Dietary ... Okra and Celery Each tablet contains : 160 Milligrams of Dehydrated Okra , 160 ... pepsin " ; " Sawall's Food Minerals Dietary Supplement Is a composition of ...

Forms Catalog

... 2579 05/90 2579 05/90 2608 11/86 2608a 11/86 Report of Assembly of a ... Application to Use Byproduct Material HFZ - 060 E Α 2979 09/76 3057 03/88 Qualifications ... Form HFZ - 340 E B HFZ - 046 E Α HFZ - 343 E B 07/25/90 FDA NO . EDITION ...

Notices of Judgment Under the Federal Food, Drug, and Cosmetic Act ...: Drugs and devices ...

... consolidate and remove the cases to its home district , the Southern District of California . Decision on the motion was held in abeyance pending the termination of the injunction proceedings filed by the claimant to enjoin the ...

Notices of Judgment Under the Federal Food, Drug, and Cosmetic Act: Drugs and devices

... for sale , the name of the repacked article , “ Les- Wate " the label statement ... Viking Sauna Corp. LABEL IN PART : ( Ctn . ) " Viking Sauna *** Producer ... Price List " ; and self - mailer entitled " Can you spare two hours a week ...

Selected Technical Publications

United States. Food and Drug Administration. Antibiotic Cross - Sensitivity - Chung & Carson Vol . 59 , No. 5 , 1976 , pp. even to dihydrostreptomycin . In con- trast , dihydrostreptomycin - sensitized hosts show cross - sensitivity to ...

Pesticide Analytical Manual

... Inc. 543 Washington St Keene , NH 03431 Scientific Glass Engineering Inc. ( SGE ) 2007 Kramer Lane Austin , TX 78758 Scientific Glass , Inc. 735 Broad St Bloomfield , NJ 07003 Scientific Products Div . American Hospital Supply Corp ...

Selected Technical Publications

... sample in blender , add 200 ml acetonitrile and 50 ml water and proceed as described above . For crops containing ... g / 325 ml 0.308 g / ml × 35 ml aliquot = 10.8 g . 4 For larger samples from 10 to 20 g , double weight of char- coal ...

Premarket Approval (PMA) Manual

... authorization cannot be withdrawn . An MAF holder should provide a letter of authorization directly to a client with instructions that : ( 1 ) the original of the authorization letter ... sample authorization letter . [ Use company letterhead ...

Radiological Health

... FDA in determining the modification history of any com- ponent or system . The agency agrees with this com- ment and ... Form FD - 2579 ( the form used by an assembler to report compliance with assembly instructions ) . Modifications ...

Radiological Health, March 1936-March 1978: Preamble Compilation

... FDA in determining the modification history of any com- ponent or system . The agency agrees with this com- ment and ... Form FD - 2579 ( the form used by an assembler to report compliance with assembly instructions ) . Modifications ...

Selected Technical Publications

... Prepare 1N solution . ( b ) Chloroform . - Redistilled from glass . ( c ) Potassium bromide . - Spectral grade . ( d ) LSD standard solution . - 100 μg LSD / ml 0.1N HCl . If LSD is not available , extract LSD - 25 as in Method I ...

FDA Report on Enforcement and Compliance

... LSD - 25 to New York City . Lowe made the sales in June and July 1965 . He was arrested October 8 , 1965 , at Los Angeles International Air- port . He changed his original not guilty plea to guilty on one count of illegal sales and two ...

Notices of Judgment Under the Federal Food, Drug, and Cosmetic Act...: Foods

... National Cranberry Assoc . , from Onset , Mass . PRODUCT : 782 cases , each containing 24 15 - ounce jars , of apricot - cranberry mix at Cincinnati , Ohio . The product was packed in transparent glass jars and had the general ...

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