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... correct violations of the Act in your facility. Your response must address comprehensively each of the violations and specific corrective actions to preclude recurrence. Include in your response steps to correct the violative products in the market...

FDA's Generic Drug Approval Process: Hearings Before the Subcommittee on ... - Page 74
by United States. Congress. House. Committee on Energy and Commerce. Subcommittee on Oversight and Investigations - 1989
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FDA's Generic Drug Enforcement and Approval Process: Hearings ..., Volume 4

United States. Congress. House. Committee on Energy and Commerce. Subcommittee on Oversight and Investigations - 1992 - 598 pages

...steps to correct the violative products in the market that were manufactured using unapproved formulas. Finally, we request your cooperation during future...suspicion and doubt of authenticity of such records. He urge your full cooperation in providing require:! records and in resolving circumstances involving...

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FDA's Generic Drug Enforcement and Approval Process: Hearings ..., Volume 4

United States. Congress. House. Committee on Energy and Commerce. Subcommittee on Oversight and Investigations - 1992 - 604 pages

...steps to correct the violative products in the market that were manufactured using unapproved formulas. Finally, we request your cooperation during future inspections of your facility. In this inspection, same records were not available when requested by the investigators, but then were made available later,...

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