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3 Takeaways from the FDA 483 to J&J Covid-19 Vaccine Maker

Vivek Gera
“Extraordinary times, take extraordinary efforts”

When Alex Gorsky (CEO, Johnson & Johnson) said this on CNBC earlier this year in March, he probably didn’t expect the manufacturing of J&J COVID-19 Vaccines to hit a pause at the Emergent BioSolutions’ factory in Baltimore. Is this going to be one of the most critical moments in our fight against Covid-19?

The scathing FDA form 483 comes just two weeks after one large production batch of J&J Covid-19 Vaccines, equivalent to 15 million doses, was ruined due to a potential mix-up with the ingredients of AstraZeneca Vaccine that was being produced in the same manufacturing facility.

In the Form 483, FDA has observed severe quality issues, although ranging across various CGMP functions, but with a central theme of cross-contamination. The observations are summarized below:

Impact of the FDA 483 on the J&J Vaccine Rollout Plan

While J&J stays committed to maintaining the vaccine supply commitments leveraging its network of, both internal and external, manufacturing sites, here are two reasons why the production pause at the Emergent plant is a significant blow to the global vaccination efforts:


Learn how Fortune 500 Pharma enterprises use CLEEN software to monitor the risk of cross-contamination

1. Emergent’s high volume business model

Emergent has had a great history of working on public health threats and has a product portfolio positioned to deal with pandemic-like situations such as Anthrax, Opioid overdose, Smallpox, and now Covid-19. Capable of producing more than one billion doses of Covid-19 vaccine in a year, the Baltimore facility of Emergent has four independent manufacturing suites, each capable of high volume manufacturing.

2. The unique positioning of J&J Vaccine

While the USA has secured enough vaccine supplies for its population, the One-Shot J&J Covid-19 Vaccine remains critical for other major economies such as Brazil, EU, and India, where governments are still struggling to ramp up the vaccination efforts. It will be of paramount importance to achieve the vaccination at the global level given the inter-dependence of the global economies.

Three key lessons for the Quality Assurance Teams

Covid-19 is far from over, and the quality issues that FDA has highlighted will have significant Ripple Effects. In some way, the Emergent case has brought a lot of attention to the quality problems that have long existed in the pharma industry. Combined with the FDA’s clear intent of resuming the facility inspections by releasing a Remote Inspections Guideline, Pharma companies need to be ready to face FDA inspections more than ever before.

There is a storm coming, Mr. Wayne

1. Look for permanent solutions, not Band-aid fixes

An interesting fact to note is that the same Emergent Facility had received an FDA Form 483 just about a year ago in April 2020 as well. Here are the links to the two FDA Form 483s:

According to an analysis we have done at Leucine based on the publicly available data from the FDA website, nearly 28% of the drug manufacturers receive a repeat Compliance Actions (Warnings / Form 483) within three years of receiving a Compliance Action. This repeat observation rate indicates that the typical way of fixing the quality issues does not result in sustainable solutions. There is a need to implement solutions that combine procedural adherence using modern technologies and assist in preventing compliance issues via proactive monitoring.

The Quality Leaders should not hesitate to collaborate with the internal or external technology teams to identify and implement solutions that drive compliance improvement using technology and data-driven Solutions.

2. Leverage Technology to transition from Periodic Monitoring to Continuous Monitoring

Traditionally, the Quality teams at pharma companies have relied upon quality assurance checks that happen before, during, and after the regulatory operations; however, these checks have three limitations

  • The quality is checked at discrete intervals
  • The checks are designed once and don’t change much after that
  • The checks are primarily driven by human decision-making.

However, with the advent of technology and the data-processing capabilities of the modern infrastructure, there is an opportunity and an urgent need to start monitoring compliance in near real time.

3. Challenge Status Quo:

At times, pharma companies tend not to take up new compliance improvement initiatives because the FDA wouldn’t have highlighted the need to make those improvements yet.

But we cleared the previous FDA audit so there’s no need to change it


It’s important to understand that lack of FDA observations in certain regulatory operations does not certify the status quo. The next inspection could be done by a whole different set of FDA inspectors with a completely different context and focus. Pharma teams need to proactively stay on top of any compliance improvement initiatives that are identified.

Cleaning Risk Management Software


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