FDA Law Blog

MAY 23, 2023

the product label declares “tree nut” or “fish” but fails to declare the type of tree nut or species of fish in either the ingredient list or in a separate “Contains” statement). The draft CPG directs FDA field staff to examine possible food product adulteration due to labeling related to allergen cross-contact.

Containment 44

Containment Contamination Manufacturing Compliance 44

The Pharma Data

APRIL 27, 2022

In particular, Action Levels for Lead in Juice: Draft Guidance for Industry , provides draft action levels of 10 parts per billion (ppb) for lead in single-strength apple juice and of 20 ppb for lead in all other single-strength juice types, including juice blends that contain apple juice. Source link: [link].

Cosmetics 52

Cosmetics Production Containment Contamination 52

FDA Law Blog

JANUARY 1, 2024

FDA stated that the firm failed to adequately test each shipment of glycerin for diethylene glycol (DEG) or ethylene glycol (EG) contamination, failed to adequately validate production and process controls, and failed to conduct a retrospective review to ensure materials previously used were suitable for their intended use.

Manufacturing 57

Manufacturing Production Drugs Contract Manufacturing 57

The Pharma Data

FEBRUARY 18, 2022

The FDA is advising consumers not to use Similac, Alimentum, or EleCare powdered infant formulas if: the first two digits of the code are 22 through 37; and the code on the container contains K8, SH or Z2; and the expiration date is 4-1-2022 (APR 2022) or later. and were likely exported to other countries. Source link: [link].

Production 40

Production Bacteria Containment Cosmetics 40

The Pharma Data

NOVEMBER 30, 2020

30, 2020 – Nearly 15% of talc-based cosmetic products analyzed in a recent study contained asbestos. Environmental Working Group (EWG) — an American advocacy nonprofit that commissioned the tests and did the analysis — said methods used by the cosmetics industry to screen talc supplies are inadequate. MONDAY, Nov.

Containment 52

Containment Production Cosmetics Contamination 52

Pharmacy Checkers

NOVEMBER 21, 2019

Wikipedia has an extremely long page aptly called Criticism of the Food and Drug Administration , much of it having to do with its role with prescription drugs, and less so other sectors, such as food, tobacco and cosmetics. . Dissecting Criticism of the FDA: Inspections & Sovaldi’s Approval.

Generic Drugs 68

Generic Drugs Manufacturing Drugs Regulation 68