C.F.R. » Title 21 » CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES › SUBCHAPTER F—BIOLOGICS › PART 610—GENERAL BIOLOGICAL PRODUCTS STANDARDS › Subpart A—Release Requirements

21 C.F.R. § 610.1

Tests prior to release required for each lot

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No lot of any licensed product shall be released by the manufacturer prior to the completion of tests for conformity with standards applicable to such product. Each applicable test shall be made on each lot after completion of all processes of manufacture which may affect compliance with the standard to which the test applies. The results of all tests performed shall be considered in determining whether or not the test results meet the test objective, except that a test result may be disregarded when it is established that the test is invalid due to causes unrelated to the product.

Notes of Decisions
Cited in 5 cases, 1986–2020 · leading case: Campagna v. Am. Cyanamid Co., 767 A.2d 996 (N.J. Super. Ct. App. Div. 2001).
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Campagna v. Am. Cyanamid Co., 767 A.2d 996 (N.J. Super. Ct. App. Div. 2001). “As a vaccine manufacturer, defendant was under an obligation at the time of plaintiff's vaccination in 1979, "to examine all vaccine lots prior to distribution to ensure that they comply with regulatory standards.”
Graham Ex Rel. Graham v. Wyeth Labs., 666 F. Supp. 1483 (D. Kan. 1987). “21 C.F.R. §§ 610.1 , 610.2. Further, the pertussis element of DPT can be produced only in conformity with 21 C.”
Hurley v. Lederle Labs., Div. of Am. Cyanamid Co., 651 F. Supp. 993 (E.D. Tex. 1986). “21 C.F.R. §§ 610.1 , 610.2. 20 . 21 C.F.R.”
Berkovitz v. United States, 822 F.2d 1322 (3rd Cir. 1987). “Each applicable test shall be made on each lot after completion of all processes of manufacture which may affect compliance with the standard to which the test applies”); 21 C.”
Belcher Pharm., LLC v. Hospira, Inc. (D. Del. 2020). “See 21 C.F.R. § 610.1 (“No lot of any licensed product shall be released by the manufacturer prior to the completion of tests for conformity with standards applicable to such product .”
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