FDA Law Blog

MARCH 20, 2022

Almost all recalls are conducted on a voluntary basis by the manufacturer. In recognition that hard copy communications are slower and more cumbersome, FDA recommends that firms use electronic communications, as they lay out the details of the electronic means here , to notify the public about recalls.

Electronics 40

Electronics Manufacturing Provider IT 40

FDA Law Blog

MAY 20, 2021

Investigators likely consult with DEA headquarters about the registrant’s compliance with required reporting and review its registration category, status, and authorized controlled substances to assess whether it may be conducting unauthorized activities. Accountability Audit.

Management 40

Management Consulting Provider Physicals 40

FDA Law Blog

MAY 20, 2021

Investigators likely consult with DEA headquarters about the registrant’s compliance with required reporting and review its registration category, status, and authorized controlled substances to assess whether it may be conducting unauthorized activities. Accountability Audit.

Management 40

Management Consulting Provider Physicals 40

FDA Law Blog

JULY 7, 2024

Laboratories struggling to understand the myriad implications of being regulated as device “manufacturers” were hopeful that additional guidance would shed light on how to apply FDA’s existing medical device regulatory framework to their operations. 803), Reporting of Corrections and Removals (21 C.F.R. § 806) and Complaint Files (21 C.F.R.

Manufacturing 64

Manufacturing Provider Physicals Electronics 64