 | United States - Law - 1977 - 1276 pages
...such device, evaluated together with the evidence before him when the application was approved, that if such establishment are subject to such inspection provisions o manufacture, processing, packing, or installation of such device do not conform with the requirements... | |
 | Administrative law - 1990 - 1086 pages
...information before FDA, evaluated together with the evidence available when the application was approved, the methods used in, or the facilities and controls...the manufacture, processing, and packing of the drug are inadequate to assure and preserve its identity, strength, quality, and purity and were not made... | |
 | Administrative law - 1992 - 1016 pages
...information before FDA, evaluated together with the evidence available when the application was approved, the methods used in, or the facilities and controls...the manufacture, processing, and packing of the drug are inadequate to assure and preserve its identity, strength, quality, and purity and were not made... | |
 | Administrative law - 1998 - 1120 pages
...ab-breviated application for a new drug under section 505<j) of the act for any of the following reasons: (1) The methods used in, or the facilities and controls...the manufacture, processing, and packing of the drug product are Inadequate to ensure and preserve its identity, strength, quality, and purity. (2) Information... | |
 | Administrative law - 2002 - 384 pages
...abbreviated application for a new drug under section 505(j) of the act for any of the following reasons: (l) The methods used in, or the facilities and controls...the manufacture, processing, and packing of the drug product are inadequate to ensure and preserve its identity, strength, quality, and purity. (2) Information... | |
 | Administrative law - 1965 - 1520 pages
...evaluated together with the evidence available when the application was approved, the methods used to, or the facilities and controls used for, the manufacture, processing, and packing of the drug are inadequate to assure and preserve its identity, strength, quality, and purity; or (3) That on the... | |
 | Administrative law - 2001 - 620 pages
...information before him evaluated together with the evidence before him when the application was approved, the methods used in, or the facilities and controls used for, the manufacture, processing, and packing of such drug or animal feed are inadequate to assure and preserve... | |
 | Administrative law - 1997 - 200 pages
...practice. The criteria in ยงยง226.10 through 226.115, inclusive, shall apply in deter-mining whether the methods used in, or the facilities and controls used for the manufacture, processing, packing, or holding of a Type A medicated articled) conform to or are operated... | |
 | Administrative law - 1988 - 772 pages
...information before him evaluated together with the evidence before him when the application was approved, the methods used in, or the facilities and controls used for, the manufacture, processing, and packing of such drug or animal feed are inadequate to 21 CFR Ch. I (4-1-88... | |
 | United States. Congress. House. Committee on Government Operations - Drugs - 1964 - 844 pages
...Administration, evaluated together with the evidence available when the application was approved, rln- methods used in. or the facilities and controls used...the manufacture, processing, and packing of the drug are inadequate to assure and preserve its identity, strength, quality, and purity : or (3) That on... | |
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... when the application was approved, the methods used in, or the facilities and controls used for, the manufacture, processing, and packing of... 
