483s in the News
When Form FDA 483s are referenced in the mainstream media, it is usually a patient injury or death that is the primary trigger. Not the kind of publicity a company wants (even if the stories focus on the FDA). Otherwise, 483s are mentioned in passing when warning letters or consent decrees are issued. Some recent examples:
- August 9, 2019, Dr. Reddy’s gets 5th FDA 484 of the year. India’s 2nd largest drugmaker is not having a good year with the FDA.
- May 16, 2019, New book raises big questions about the safety of generic drugs. Katherine Eban’s new book, Bottle of Lies, has received worldwide coverage on how many Indian and Chinese companies prepare for FDA inspections through falsifying data, destroying documents, and even bugging inspector’s hotel rooms.
- August 15, 2019 RAP crunches the numbers on FDA inspections and 483s in India and China. “A closer look at 2017 shows again just how much work the agency puts into these two countries and how no two situations are alike. For instance, many of the manufacturing sites are inspected multiple times per year, and some companies receive multiple Form 483s for the same site.”
- May 9, 2018, In The Spotlight: Evolus by RTT News. The FDA had conducted a cGMP and pre-approval inspection of Daewoong’s manufacturing facility in South Korea last November, and had issued an FDA Form 483 with ten inspectional observations to Daewoong to take corrective actions.
- May 8, 2018, Rodents, insects, poor sanitation found at Rose Acre egg facility by Dan Flynn. Inspector observations shared with the complex manager at Hyde County Egg, owned by Rose Acre Farms, shortly before the announcement of the multistate outbreak of Salmonella Braenderup don’t paint a pretty picture.
- May 3, 2018, FDA Issues New Form 483 to Biocon Over Bangalore Facility by Kelly Davio. Biosimilar developer Biocon has received the FDA’s Form 483 after a preapproval inspection of its Bangalore manufacturing facility resulted in 7 observations.
- October 10, 2017, Mylan and Biocon biosimilar of Amgen’s Neulasta hit with manufacturing-related CRL by Eric Palmer. An example of when a 483 solution causes a CRL problem. Sometimes these sites just can’t seem to win.
- August 8, 2017, FDA slams Biocon sterile plant where Herceptin biosimilar is to be produced by Eric Palmer. 8 pages + 10 observations = a single 483 causing “costly delays.”
- July 31, 2017, Trouble Mounts For Biocon’s Bengaluru Plant by Yatin Mota. 3 inspections in 3 months = 1 company surely on the FDA’s radar (plug – we’re cited in the article!)
- July 31, 2017, Dr. Reddy’s plant remediation efforts still months away from completion by Eric Palmer. It’s not a myth. 1 single warning letter can = 2 years lost at 3 sites.
- July 13, 2017, FDA: Lead Test Company May Have Violated Federal Law by Michael Mezher. Have you noticed that the FDA continues to put customer complaints (especially w/med devices) at a premium? It’s at the heart of this 11 page 483 found at the bottom of the article.
- May 9, 2017, FDA Warns Lonza’s Class II Device Manufacturing Site by Zachary Brennan. What’s unique about this warning letter is its speed. Issued a mere 2.5 months after its inspection, it may show that the FDA is quickening its pace in more ways than one.
- May 1, 2017, FDA cites third Dr. Reddy’s plant this year by Eric Palmer. Three 483s in 4 months. Not only does it show that the FDA knows where to look, but it’s also proof that the FDA isn’t afraid to make a very loud statement.
- April 25, 2017, Vulto Raw Cheese Listeria Outbreak: FDA’s Form 483 Released by Linda Larsen. 54 Listeria positives + 1 employee’s arms (with multiple cuts and abrasions) elbow-deep in the cheese = 15 observations in a 10-page 483.
- April 6, 2017, A Peek Behind the Curtain: 706 FDA Form 483 Requests in 2016 for Indian and Chinese Manufacturers by Zachary Brennen. If you asked the FOIA for a 483 from China or India last year, your name is in this article. But, not if you got the 483 from us. This is exactly why we do what we do.
- March 9, 2017, Barron’s Asia: Dr. Reddy’s Tumbles 4% After US FDA Inspections Find More Trouble by Shuli Ren. We all know that some 483s are worst than others. But, last Thursday, investors didn’t wait for details. They jumped ship after hearing a single sentence: “We have been issued a Form 483 with 13 observations.”
- March 8, 2017, RAPS: FDA Warns Wockhardt Subsidiary, Says Seven of Company’s Facilities Out of Compliance by Michael Mezher. This is more than a story of 1 company receiving countless warning letters. It’s proof that once you get on the FDA’s radar, they never take their eyes off of you.
- March 1, 2017, RAPS: FDA Warns China API Manufacturer for Data Integrity Violations by Michael Mezher. 7 computer tests but only 6 computer results = 1 irate inspector. Remember, the FDA will always want complete data…never just the correct data.
- February 18, 2017, FiercePharma: Teva catches break as warning letter looks to delay Momenta Copaxone generic by Eric Palmer. 17 months. That’s the average length of time it takes companies to resolve 1 warning letter. More stats from EvercoreISI (based on 20 years of cGMP data) is found at bottom of article.
- February 8, 2017, FiercePharma: Sanofi CEO believes application-killing problems at fill-finish plant fixed this time around by Eric Palmer. How do you recover from being slammed with a 483/CRL to being deemed FDA “acceptable”? Keep your friends close but the FDA closer.
- January 17, 2017, RAPS: FDA Form 483 Cites 14 Observations for Zimmer Biomet by Zachary Brennan. 3 FDA inspectors + 22 inspection days = 1 intense situation and a 58-page 483.
- January 4, 2017, FiercePharma: Fire at Sun API plant in India kills two, injures two others by Eric Palmer. Being hit with a 483, a warning letter, and a fire is challenging for any company. But, stating that “this is not a material event” and that it does not “have any bearing on operations/performance” may do more harm than good.
- November 29, 2016, FiercePharma: Analysts say Sanofi plant failings could pose issues for 2 expected blockbusters by Eric Palmer. How do you recover from receiving a 483 and (just 4 months later) a CRL? With comprehensive corrections and a “healthy dose of contrition.”
- November 7, 2016, RAPS: FDA Issues 483 to New Jersey Sterile Drug Producer by Michael Mezher. 1 clean facility + 2 unclean hands = 7 observations in a single 483.
- October 28, 2016, FiercePharma: UPDATED: Sanofi and Regeneron’s expected blockbuster hit with FDA CRL for manufacturing concerns by Eric Palmer. CRL > BLA (Biologics License Applications). Even when $1.8 billion in sales and countless patients with rheumatoid arthritis are waiting.
- October 24, 2016, RAPS: FDA Targets 15 Hospitals Over Significant Deviations from Medical Device Reporting Regulation by Zachary Brennan. Manufacturer VS User. Who should receive the 483? After 10 days of no reporting, the FDA answers ‘user’.
- October 19, 2016, FiercePharma: Teva’s struggling sterile plant hit with FDA warning letter by Eric Palmer. Aspiring Leader of Generics is buying out but also cleaning up.
- October 3, 2016, MedDeviceOnline: Understanding The 4 Types Of FDA Inspection by Peter Ohanian. Info on the go. An inspection snapshot for all, and a QSIT run-through for medical devices.
- September 6, 2016, RAPS: FDA Hits Valeant’s Bausch & Lomb With Form 483 by Zachary Brennan. An 18 day inspection + 2 inspectors (can sometimes) = an 8 page 483.
- August 9, 2016, FiercePharma: Alexion issued new FDA Form 483 for Rhode Island plant by Eric Palmer. The world’s most expensive drug, Soliris, hit with a 483.
- February 10, 2016, RAPS: US FDA Inspections in China: An Analysis of Form 483s from 2015 by Zachary Brennan. See how the FDA operates in the two countries that own 80% of the world’s APIs.
- March 11, 2011, MSNBC: Under pressure, firm closes line that made tainted wipes by JoNel Aleccia
- February 22, 2011, MSNBC: FDA knew of problems at plant that made tainted alcohol wipes by JoNel Aleccia. This story was MSNBC’s lead story for an entire morning. While other news channels were leading with the riots in Libya, MSNBC chose to keep this as the lead story for several hours on their home page. FDAzilla.com, referenced in the lower half of the article, saw more than 10,000 views originating from the article, suggesting that this article was viewed by millions)
- February 15, 2011, MSNBC: Parents blame toddler’s death on tainted alcohol wipes by JoNel Aleccia
- Here’s the 483 that started it all.H&P industries (Triad Group) FDA 483 1-7-2011
