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" be sterile which are adulterated within the meaning of 21 USC 351(a)(2)(B) in that the methods used in and the facilities and controls used for the manufacturing, processing, packing, or holding of said articles do not conform to and "
Hearings, Reports and Prints of the Senate Select Committee on Small Business - Stranica 16198
napisao/la United States. Congress. Senate. Select Committee on Small Business - 1978
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Code of Federal Regulations: Containing a Codification of Documents of ...

1985 - Broj stranica: 1006
...control of the product. An application may be refused unless it includes adequate information showing that the methods used in, and the facilities and controls used for, the manufacturing, processing, and packaging, of the new animal drug are adequate to preserve its Identity, strength, quality, and...
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Code of Federal Regulations: Containing a Codification of Documents of ...

1990 - Broj stranica: 782
...control of the product. An application may be refused unless It Includes adequate information showing that the methods used in, and the facilities and controls used for, the manufacturing, processing, and packaging of the new animal drug are adequate to preserve its identity, strength, qua]¿onformltywith...
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Code of Federal Regulations: Containing a Codification of Documents of ...

1975 - Broj stranica: 462
...control of the product. An application may be refused unless it includes adequate information showing that the methods used in, and the facilities and controls used for, the manufacturing, processing, and packaging of the new animal drug are adequate to preserve its identity, strength, quality, and...
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Code of Federal Regulations: Containing a Codification of Documents of ...

2000 - Broj stranica: 698
...control of the product. An application may be refused unless it includes adequate information showing that the methods used in, and the facilities and controls used for, the manufacturing, processing, and packaging of the new animal drug are adequate to preserve its identity, strength, quality, and...
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Code of Federal Regulations: Containing a Codification of Documents of ...

1998 - Broj stranica: 588
...control of the product. An application may be refused unless it includes adequate information showing that the methods used in, and the facilities and controls used for, the manufacturing, processing, and packaging of the new animal drug are adequate to preserve its identity, strength, quality, and...
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Code of Federal Regulations: Containing a Codification of Documents of ...

1999 - Broj stranica: 596
...control of the product. An application may be refused unless it includes adequate information showing that the methods used in, and the facilities and controls used for, the manufacturing, processing, and packaging of the new animal drug are adequate to preserve its identity, strength, quality, and...
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Code of Federal Regulations: Containing a Codification of Documents of ...

1975 - Broj stranica: 742
...control of the product. (An application may be refused unless It includes adequate Information showing that the methods used In, and the facilities and controls used for, the manufacturing, processing, and packaging of the drug are adequate to preserve Its Identity, strength, qualIty, and purity In conformity...
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Code of Federal Regulations: Containing a Codification of Documents of ...

1997 - Broj stranica: 580
...control of the product. An application may be refused unless it includes adequate information showing that the methods used in, and the facilities and controls used for, the manufacturing, processing, and packaging of the new animal drug are adequate to preserve its identity, strength, quality, and...
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Code of Federal Regulations: Containing a Codification of Documents of ...

1995 - Broj stranica: 1360
...control of the product. An application may be refused unless it includes adequate information showing that the methods used in, and the facilities and controls used for, the manufacturing, processing, and packaging of the new animal drug are adequate to preserve its identity, strength, quality, and...
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Code of Federal Regulations: Containing a Codification of Documents of ...

1968 - Broj stranica: 656
...control of the product. (An application may be refused unless it includes adequate information showing that the methods used in, and the facilities and controls used for, the manufacturing, processing, and packaging of the drug are adequate to preserve its Identity, strength, quality, and purity in conformity...
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