42 U.S.C. § 300aa–28 — Manufacturer recordkeeping and reporting

(a) General rule: Every manufacturer of a vaccine listed in the Vaccine Injury Table — or of any other vaccine a state requires by law — must, for each batch or lot made or licensed after December 22, 1987: (1) keep records showing the full manufacturing, processing, testing, repooling, and reworking history of that batch, including any major problems found while making, testing, or handling it; (2) if a safety test suggests the batch could pose an immediate or serious public health danger, report this to the Secretary within 24 hours of the test — including the test date, vaccine type, batch identity, whether the batch came from repooling or reworking earlier batches (and if so, which ones), the full test results, and who ran the test; (3) attach to each such report a signed certification from a responsible company official that the report is true and complete; and (4) keep, and give the Secretary on request, records showing where each batch was distributed. (b) Sanction: A manufacturer that intentionally destroys, changes, fakes, or hides a record or report required by (a)(1) or (a)(2) faces: (1) a civil penalty of up to $100,000 per violation, or (2) a fine of $50,000, up to 1 year in prison, or both. This penalty applies to the person who did the destroying, changing, faking, or hiding; to the person who ordered it done; and to the manufacturer that person works for. Each act of destroying, changing, faking, or hiding a record counts as a separate violation.