FDA-Regulated Industry

/FDA-Regulated Industry

Who Can See Form FDA 483s, and Where Do I Get Them?

Form FDA 483s are central to anyone’s FDA inspection preparation program. As the keeper of the world’s largest database of FDA 483s, we often get asked, “How do you get a hold of actual 483 reports and who else can see them?” This is where things get a little tricky. Theoretically, Form FDA 483s are public information and, thus, [...]

By | 2018-07-05T16:26:50+00:00 July 5th, 2018|Biopharma / Pharma, CGMP, FDA Inspections, Form FDA 483, Medical Devices|

GMP Regulatory Newsletter: Summary Scan | Week of 6/24/18

Laws, Regulations, Guidance, and Concept Papers: Guidance documents this week were from the FDA, EMA, and HPRA. Among the FDA ones are 2 programs where FDA will further pursue and investigate criteria for their Quality metrics program. The non-guidance documents include publications from MHRA, EMA, FDA, TGAA, and ICH.  Several are worth a serious read. To see the complete [...]

How to Monitor and Benchmark Your CMOs/Suppliers

Today I’d like to show you how to do supplier monitoring and benchmarking using FDAzilla Enforcement Analytics. We’ll start with a simple example of API manufacturers located outside of the United States. You can either watch this video to see how we do this or continue reading below. [NOTE: Don't have access to FDAzilla Enforcement Analytics? Get your personalized [...]

Week of June 17th 2018 | FDA Sent These Warning Letters to Pharma Companies

FDA posted 15 warning letters this week -- many issued by the Center for Tobacco Products, and 3 issued for firms in the areas we cover. GLP STUDIES, BIMO: Benedict S. Kiao, MD, at the Oeyama-Moto Medical Group Foundation, Inc (West Covina, CA) received a warning letter dated May 21st 2018, based on the outcome of an inspection conducted [...]

Part 1: Drug GMP Warning Letters Data Governance and Data Integrity

This Special Report represents the 3rd year that we have published an evaluation of warning letters associated with data governance and data integrity deficiencies. Failures in data integrity and data governance is an enforcement area that began almost 20 years ago and continues to increase in visibility and number of warning letter enforcement actions. FDA is not the only [...]

GMP Regulatory Newsletter: Summary Scan | Week of 6/17/18

Laws, Regulations, Guidance, and Concept Papers: Lots of PIC/S guidance this week along with a couple from the FDA and EMA and 1 each from MHRA and HPRA. FDA’s withdrawal of a draft biosimilar guidance is in response to industry concerns about the bar that was set in establishing biosimilarity over time. It will be interesting to see the [...]

Week of June 10th 2018 | FDA Sent This Warning Letter to a Pharma Company

A slow warning letter week, 3 from the Center for Tobacco Products and 1 issued to a pharma manufacturer that we address below: Want to see the complete list of enforcement documents — including recalls, alerts, and import alerts from this week? Start your FREE trial of the GMP Regulatory Newsletter today. Taiwan Biotech Company Ltd (Taiwan R.O.C.) received a [...]

How Do I Apply ALCOA To E-Records?

It’s easier than you think! Let’s... Start with a paper record example Explore how to apply ALCOA to electronic records Point out 3 warning signs on the trail to data integrity ALCOA in the Paper World ALCOA defines the generally accepted standard for GLP and GCP data quality and data integrity. Let’s use paper CRFs at a clinical investigator’s site as a starting [...]

By | 2018-06-21T13:33:46+00:00 June 21st, 2018|Biopharma / Pharma, CGMP, FDA Inspections, Medical Devices|

GMP Regulatory Newsletter: Summary Scan | Week of 6/10/18

Laws, Regulations, Guidance, and Concept Papers A busy week on the guidance publication front for FDA, WHO, HPRA, and Health Canada. A busy weekend of reading material! Among the most important from the FDA is the 21-page item on alternative mechanisms for complying with the GMPs for combination products. The non-guidance area includes the usual collection from MHRA (including [...]