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Annual Report – FY 2018

A comprehensive annual overview of the most frequently cited cGMP violations from actual FDA inspections. This 30-page report graphically depicts inspection observations by category and provides specific detail from actual 483 reports.

Annual Report – FY 2019

A comprehensive annual overview of the most frequently cited cGMP violations from actual FDA inspections. This 30-page report graphically depicts inspection observations by category and provides specific detail from actual 483 reports.

Annual Report – FY 2020

A comprehensive annual overview of the most frequently cited cGMO violations from actual FDA inspections. This report graphically depicts inspection observations by category and provides specific details from actual 483 reports.

FY 2023 Review of FDA Inspections

[…] procedures are not established which of those manufacturing processes that may be responsible for […]

Annual Report – FY 2021

The GMP Trends® Annual Report is a review of FDA Inspection Observations for the previous […]

FY 2022 Review of FDA Inspections

[…] all capsules is expected due to the manufacturing, cleaning, and sorting processes. The root […]

GMP Sample Newsletter 2023

[…] REPORTS OF FIRMS (I) (WE) OBSERVED : MANUFACTURING CONTROLS 1. …..There is a failure to […]

GMP-Sample-Newsletter-2024

[…] REPORTS OF FIRMS (I) (WE) OBSERVED : MANUFACTURING CONTROLS 1. …..There is a failure to […]

Issue #1132

[…] actual 483 observations pertaining to quality systems, manufacturing controls, and medical device manufacturers. This issue […]

Heartware, Inc.

Actual FDA 483 Observation Reports