Application Note: How to Respond to (and Avoid) Form 483s

This application note gives a 10 point plan for responding to a Form 483 and features several excerpts from common deviations noted in Form 483s.

Aug 13th, 2013
Fda Hi Res Copy
Saleable Returns Verification Delayed to 2023
Additional three-year delay: FDA guidance says distributors will not be required to verify the product identifier of returned drugs before resale until Nov. 27, 2023.
Oct 23rd, 2020
Gavel 5efd2dbada95c
Cannabis Policy Vote May Happen by End of 2020
The MORE Act would be historic in that it would remove cannabis from the Controlled Substances Act, opening a path for regulations to follow.
Oct 1st, 2020
Alignment 90 Sep Oct 2018
Live from PDA/FDA: FDA Considers Incentivizing Quality Management Maturity (QMM)
The Agency is soliciting feedback from manufacturers on assessing and rewarding QMM through Oct. 2020. Reduced audit frequency may one day be an incentive for high performers.
Sep 15th, 2020
C Ph I Fo P On White With Dates
CPhI Festival of Pharma 2020 in October
Former FDA commissioner Dr. Scott Gottlieb to address industry on sustainable innovation at the two-week long event. Sessions will cover affordable medicines, supply change resiliency, AI, Vaccine production, and more.
Sep 9th, 2020
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Smithers tests med devices
Smithers, a leading provider of testing, consulting, information, and compliance services, has announced the formation of the Medical Device Testing division.
Jul 20th, 2020
Udi
Med Devices and the FDA: Extended Deadline, Worker Safety
In extending UDI compliance dates for low-risk products, FDA cited challenges related to COVID-19. CDRH also issued recommendations for personnel safety in med device manufacturing.
Jul 17th, 2020
FDA Commissioner Dr. Stephen Hahn
New FDA Insight Podcast on Emerging Topics
First guest: FDA commissioner Dr. Stephen Hahn on fighting COVID-19 at FDA.
Jun 24th, 2020
Allergan
Quick Hits: Allergan is Seeking Women with Recalled Breast Implants
Allergan recalled breast implants more than 10 months ago; now they are trying to find the women who still have them.
Jun 12th, 2020
Fitbit Ventilator
Quick Hits: FDA Gives Emergency Approval to Fitbit’s Ventilator
The wearable tech company developed a new ventilator to help treat the current health crisis.
Jun 9th, 2020
Getty Images 1127958533 Drug Prices
States Focus Legislation on Prescription Drug Costs
Though attention has turned to COVID-19, state legislatures were already pivoting away from last year’s opioid legislation to address drug prices—an issue that requires the Healthcare Distribution Alliance to engage across all 50 states.
May 14th, 2020
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Take PDA's COVID-19 Survey in Pharmaceuticals
The Parenteral Drug Association (PDA) is conducting an important assessment to understand industry impacts on operations and supply chains.
Apr 6th, 2020
Honeywell Bigfinite Collaboration 300 Dpi
Honeywell Collaborates With AI Specialist Bigfinite to Speed Medical Therapies
The collaboration will focus on helping biotech and pharma industries understand and make use of artificial intelligence and machine learning to enable faster development.
Feb 10th, 2020
World Health Organization (WHO) declared the Wuhan coronavirus outbreak a global health emergency.
W.H.O.: Global Emergency Declared as Wuhan Coronavirus Spreads
Most of the 8,000 cases have been reported in mainland China.
Jan 30th, 2020
Eric G
Feds Say Not Legal, But Still It’s Not Rare: Why’s CBD for Sale Everywhere?
In our column’s continuing effort to correct common misconceptions about packaging law, this month we turn to cannabidiol, or CBD.
Jan 29th, 2020
Un Pac Ked Podcast Graphic
Cannabis Packaging: Don't Fear the Reefer
UnPACKed with PMMI Podcast breaks down the latest developments in cannabis packaging as more and more states open the door to legalization.
Jan 23rd, 2020
Unknown
Controversial new labeling idea
Headlines from the U.K. sound promising but reading deeper reveals very little benefit for contemplating such a major change for food manufacturers.
Dec 28th, 2019
Activ-Blister Packaging / Image: Aptar
FDA Approves Activ-Blister™ Packaging for HIV Drug
The FDA has approved AptarGroup’s packaging solution for oral solid dose HIV prevention medicine.
Oct 25th, 2019
Holographic foils can be used to great effect to differentiate product at the point-of-sale.
Using Holography to Fight Pharmaceutical and Healthcare Brand Piracy
Column: New trends in pharma packaging follow developments in emerging markets, demographic changes and new technologies that include holography, says chairman of the International Hologram Manufacturers Association.
Oct 24th, 2019
Baby Powder / Image: Flickr
FDA Finds Asbestos in Baby Powder, Recall Ensues
Johnson & Johnson recalled thousands bottles of their famous baby powder after the FDA found trace amounts of asbestos.
Oct 24th, 2019
Yourway Mitigates Uncertainty of Brexit for Clinical Trials in Europe
Their new location is strategically placed to accommodate both the UK and mainland Europe.
Oct 21st, 2019
More in Regulatory
Digital Network Platform to Further Transform the Global Pharmaceutical Supply Chain
TraceLink: Digital Network Platform to Further Transform the Global Pharmaceutical Supply Chain
The platform is designed to allow users to rapidly design and deploy network orchestration and analytics applications, enabling patient-centric orchestration across the end-to-end life sciences value chain.
Oct 17th, 2019
Schreiner MediPharm's Flexi-Cap Prime has a combined tear strip for the label and cap
Schreiner MediPharm: Tamper-Evident Flexi-Cap Prime for Vials
The tear strip is designed to ensure that undetected reuse of a container is no longer possible.
Oct 16th, 2019
Duane Niedert, Director of Operations – Americas for Smithers
Smart Packaging: ‘A Tale of Two Technologies’
A presentation at SmartPack 2019 delves into the current status, forecast, and drivers of the two categories of technology—smart and active—that make up smart packaging.
Oct 15th, 2019
Migrane Drug Needed / Image: Getty
FDA Approves New Acute Migraine Drug
Eli Lilly’s new drug Reyvow relieves pain, nausea, and light sensitivity in within two hours of ingestion.
Oct 14th, 2019
Descovy / Image: Gilead
FDA Approves HIV Drug, But Only for Men
Gilead Sciences only tested Descovy on men and transgender women, and the approval explicitly excludes cisgender women.
Oct 10th, 2019
Zantac and generic versions of the popular heartburn medicine face concerns about contaminants.
How QR Codes Can Help Drug Makers Streamline Recalls
Concerns about a carcinogenic impurity have prompted recalls of Zantac and generic versions of the popular heartburn medication. Smart labeling technology could speed and clarify alerts to consumers and also help drug companies reduce scrapped lots.
Oct 9th, 2019
Infant Werewolf Syndrome / Image: Shutterstock
Mislabeling Leads to 17 Cases of Infant “Werewolf Syndrome”
Children in Spain have developed hypertrichosis after a reflux drug was contaminated with alopecia treatment.
Oct 9th, 2019
Visible Particulate FDA Recall Notices by year as compiled by John Shabushnig, Insight Pharma Consulting, from FDA data. Reprinted with permission.
Particles in Parenterals: 2019 Update
FDA expects a visual inspection program and parenteral manufacturers should expect questions about their program during any inspection. What's new in 2019?
Oct 4th, 2019
Toshiba’s new thermal barcode printer, the B-EX4T3HS, prints at 600 dpi at speeds up to 6 in/s.
High-Precision Printer Eases Compliance in Medical Packaging
Toshiba’s latest thermal barcode printer combines high-resolution printing with high precision in label feeding to print small labels.
Oct 3rd, 2019
Opioids / Image: iStock
FDA and DEA Target More Illegal Opioid Websites
In the continued fight against the opioid crisis, the FDA and DEA issued joint warning letters to websites illegally marketing and selling opioids.
Oct 3rd, 2019
Systech, a global technology provider of digital brand protection and authentication, launched its Systech Brand Protection Suite™.
Digital Brand Protection: Fingerprinting for Serialized and Non-Serialized Products
Systech’s next-generation platform is a brand protection suite that integrates fool-proof product authentication with serialization, traceability and insight.
Oct 2nd, 2019
NUsurface Meniscus Implant / Image: Active Implants
First Artificial Meniscus is an FDA Breakthrough Device
The FDA has designated the first artificial meniscus implant a breakthrough device, expediting its review process.
Sep 26th, 2019