Pet Food Recall 2024: FDA Issues Advisories Over 2 Brands

Sep 25, 2024 · The FDA found Salmonella and Listeria in samples of several pet food brands. IE 11 is not supported. For an optimal experience visit our site on another browser.

Production and Process Controls - U.S. Food and Drug …

Oct 8, 2018 · Quality Production Laboratory Materials Facilities and Equipment Packaging and Labeling Drug Regulation Framework Statute FD&C Act Section 501(a)(2)(B)

Frequently Asked Questions About Combination Products | FDA

Aug 16, 2022 · A final rule on CGMP requirements for combination products identifies what CGMP requirements apply to combination products (codified at 21 CFR 4) and options for demonstrating compliance with them.

Pharmaceutical Quality Control Labs (7/93) | FDA

5 days ago · In addition to the general approach utilized in a drug CGMP inspection, the inspection of a laboratory requires the use of observations of the laboratory in operation and of the raw laboratory ...

FDA cGMP Training Program - ppt download - SlidePlayer

41 Wrongful Acts Any act or conduct that subverts the integrity of the review process, including, but not limited to the following: submitting fraudulent applications offering or promising a bribe or illegal gratuities making an untrue statement of a material fact (e.g. false statement, a misstatement or an omission of a fact) submitting unreliable data which results from system …

OTC Drug Review Process | OTC Drug Monographs | FDA

Jul 25, 2024 · The Over-the-Counter (OTC) Drug Review was established to evaluate the safety and effectiveness of OTC drug products marketed in the United States before May 11, 1972.

Newly Added Guidance Documents | FDA

Oct 25, 2023 · Topic Guidance Status Date; Current Good Manufacturing Practice (CGMP), Pharmaceutical Quality: Remote Interactive Evaluations of Drug Manufacturing and Bioresearch Monitoring Facilities

The Use of Mechanical Calibration of Dissolution Apparatus …

Jun 15, 2024 · This guidance is intended to aid drug manufacturers (including ancillary testing laboratories) in calibrating U. S. Pharmacopeia (USP) Dissolution Apparatus 1 and 2 to help assure that critical ...

FDA Inspectional Observations and Corrective Actions

Oct 8, 2018 · 5 Lack of Routine Surface, Personnel, and Viable and Nonviable Air Count Air Monitoring – Corrective actions, what’s needed: • Environmental/personnel monitoring SOPs that address

Pharmaceutical Inspections and Compliance | FDA

Jun 10, 2024 · The information below explains the actions FDA takes to accomplish this goal through CGMP inspections that evaluate drug manufacturers’ compliance with CGMP requirements and the actions that can ...