Resources

I started the QAPharm Blog three years ago as a creative outlet to share my perspective on the pharma industry and the quality assurance profession. I have appreciated my faithful readers from dozens of countries around the world. For years, we’ve been following The QA Pharm Blog. Writen with an equal dose of deep industry […]

We receive a lot of questions, especially from our international colleagues, about how FDA 483s are actually written – the whole “lifecycle”, if you will. Based on manuals and other FDA resources that are publicly available, we answer your 10 most frequently asked questions in this area. Especially if you are new to FDA 483s, […]

In another significant slip, inspectors found that Zorro Technology had not given employees any training in cGMPs (or at least couldn’t prove that they had). Today is our last strategy for avoiding cGMP 483s – make sure QA employees are adequately educated, trained and supervised. Again, this may seem obvious, but in a cutthroat environment […]

Abbott Nutrition was cited a few years ago for failing to exclude pests from processing areas. This was the plant’s 31st citation related to warehouse beetle infestations since 2007. This one may seem obvious, but since it comes up repeatedly in the 483 batch from 2012, let’s say it again. If the FDA cited you […]

We just got the updated list of FDA inspections and FDA 483s – it goes from January 2010 through June 15, 2013. You can purchase the entire spreadsheet (in .xls format) through this link for $569. Great to look for macro trends by region (global, international, or even state level) or to dig deep into […]

Meridian Medical Technologies was cited when inspectors saw a something “which appeared rust-like…on the bottom of the stainless steel plate located across the top of the window in Room [b] in the class [b] area where EpiPen NGA is manufactured.” Ventilation problems. Rust on the walls. Drips in the pipes. Not only are these ugly, […]

Wyeth was dinged by inspectors when it failed to follow its own written procedures for sampling and testing—specifically failing to test at the beginning, middle and end of manufacture for its ChapStick Medicated Stick. It also got cited for failing to follow its own procedures for handling consumer complaints. It’s hard to tell which upsets […]

During this August, FDA 483s month here at FDAzilla, we repost some of our favorite pieces related to 483s. Here’s another from the QA Pharm. This is the second of a two-part series that addresses underlying obstacles to management oversight of the pharma quality management system as evidenced by the continuing serious compliance and product […]

In a recent 483, Baxter was cited for falling short on two exception verifications. This included failing to be sure that lots placed on QA hold had extended to all physical locations relevant to the hold. Baxter also got slapped for failing to be sure that components and containers weren’t withheld from use until the lot […]

Formulation Technology was hit with a 483 when inspectors found that testing and release of drugs made there didn’t include “appropriate laboratory determination of satisfactory conformance to the final specifications prior to release.” The FDA is increasingly impatient with manufacturers who skip steps or cut corners in the final steps of the quality control process. […]