Resources

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. […]

In one extreme case, an FDA inspection concluded that Zorro Technology didn’t have written quality control procedures at all, that drug ingredients weren’t identified in terms of their status, and that batch records identifying the weight of compound quantities to be added weren’t present. Of late, inspectors are getting tougher about documentation requirements. In some […]

As you prepare for your next FDA inspections, bear in mind some of the key focus areas, which were high priorities for FDA inspectors in the last few years—all driven by patient safety concerns, according to a top pharma executive: Poor quality investigations of customer complaints, adverse events, significant deviations and out of specification results.Failure […]

When all is said and done, avoiding FDA 483s depends most heavily on the organization’s expectations and culture. Attention to quality has to permeate an entire organization from the top down and the bottom up, our panel said. Employees need to be motivated and incentivized to create products of the highest quality, and managers have […]

During weekends in August, FDA 483s month here at FDAzilla, we repost some of our favorite pieces related to 483s. Here’s a memorable story of an inspection in Costa Rica. The FDA had sent one of their best and toughest inspectors. The facility was located in Costa Rica. I had been sent there from the US […]