FDA Law

AUGUST 10, 2023

Cato — On August 3rd, FDA issued 11 warning letters to foreign facilities registered as OTC drug manufacturers. FDA has resumed on-site inspections of foreign facilities focused on current Good Manufacturing Practices (cGMP) but has continued issuing records requests under Section 704(a)(4), which spurred this latest round of warning letters.

Manufacturing 52

Manufacturing Electronics IT Physicals 52

FDA Law

SEPTEMBER 22, 2024

MDR FDA discussed a few preliminary steps that it says laboratories should take prepare for submitting MDRs as medical device manufacturers. SCG : Modified version of another manufacturer’s FDA-authorized test within scope described in preamble to LDT Final Rule. SCH : LDT, approved by NYS CLEP. It should be noted that 21 CFR 803.18(b)(1)(ii)

Manufacturing 64

Manufacturing Electronics Provider Management 64

FDA Law

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

MAY 20, 2021

Registrants must account for all of the controlled substances they receive, manufacture, or otherwise handle, so it is important that registrants document all controlled substance movement from receipt to transfer from the facility or disposal. Accountability Audit.

Management 40

Management Consulting Provider Physicals 40

FDA Law

MAY 20, 2021

Registrants must account for all of the controlled substances they receive, manufacture, or otherwise handle, so it is important that registrants document all controlled substance movement from receipt to transfer from the facility or disposal. Accountability Audit.

Management 40

Management Consulting Provider Physicals 40

FDA Law

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

FDA Law

MAY 21, 2024

and its abuse may lead to only moderate or low physical dependence or high psychological dependence. Public comments must be submitted electronically or postmarked on or before July 22, 2024, 60 days after publication in the Federal Register. 21 U.S.C. § 21 U.S.C. § Basis at 61; NPRM at 44,615. at 44,617, 44,619. Basis at 64-65.

Physicals 69

Physicals Medical Clinic Emergency Room 69