Guest column : The ‘sin’ that led to an #FDA inspection #pharma #quality

Ajit KamathYou can imagine the trepidation of a pharmaceutical company when the US Food & Drug Administration (FDA) comes calling. Given the demanding nature of inspections, recent enforcement actions and the public scrutiny that each warning letter is subjected to, even a battle-ready manufacturing site with the most stouthearted management can’t help but feel a ripple of nervous tension.

Now, consider the situation if the visit were wholly unexpected.

Really, why us?

This is what happened to us. One Friday afternoon in March, our human resources (HR) department got a call. It was the US Food & Drug Administration (FDA). They wanted directions to a site that our company owns in Hyderabad. The site makes early and late stage intermediates for captive and third party consumption. An FDA inspector, we were told, would be in early Monday morning for an inspection.

Now, our HR department is not in the habit of fielding calls from the FDA. More importantly, Sibra, as the site is know internally, is targeted at India and other Asian markets including Japan. It has never filed a US Drug Master File (DMF), has no history of exports to the US and no immediate intentions of doing so! We wondered if someone was hoaxing us.

So we actually dialled back. It was the FDA alright. And the inspector, we were informed politely, was coming whether we liked it or not. When we asked for a deferral, they declined.

All hell broke loose. Old records were pulled out to see what, possibly, could have triggered this visit. As it turned out, sometime in 2014, an overzealous colleague from our Regulatory Affairs department had filed an application for a Site Identification Number (SIN) with the FDA.

A SIN is essentially a record of the coordinates/location of a facility. Someone had casually mentioned that a SIN was a “good thing to have” for if you ever wanted to export to the US you could tell your customer to include the SIN in its ANDA or DMF filings.

In his wisdom, this colleague had filed a SIN and mistakenly provided the HR department’s contact (and not the admin department’s as is the usual practice). The SIN was, apparently, reason enough to trigger an inspection.

Double-edged sword

We went into a huddle. We had everything to gain from a successful inspection. It would ensure that, if we wanted, we could use this facility for making any product for the US for an average length of two years (until the next inspection) as long as we stayed compliant.

But some colleagues had reservations. What if there were significant ‘observations’ by the FDA, they asked? The ripple effects would be felt by the three FDA-approved facilities of the company currently exporting to the US. FDA inspectors might swoop down on all three in parallel, they warned. And the scrutiny quotient might double.

We got on the phone with colleagues from the industry. They were taken aback that a SIN could lead to an inspection. But didn’t think there was cause to worry as the site had no DMF filings. “It will end in 15 minutes,” we were told.

So I have to admit, rather shamefacedly, that this didn’t really ruin our weekend. It will be over soon, we told ourselves. We were wrong.

It lasted five whole days. Just as the length of a minute depends on which side of the bathroom door you are on, those five days felt like the longest we had witnessed in our history of regulatory inspections.


But there is a God. We ended up with all of two Form 483 observations both of which we speedily addressed. One was about personnel assigned conflicting staffing roles (doers were checkers). The second related to equipment calibration and validation.

Since that day in March, the inspector has signed off on our Establishment Inspection Report. Sibra is now our fourth FDA-approved facility! Internally, we likened this event to Afghanistan lifting the Cricket World Cup.

Arch has been through FDA inspections before. But some things stood out this time. Chief among them was the inspector’s training in and deep-dive into quality control. There was an element of the ‘forensic’ in the nature of the inquiry. I attribute this to the data integrity issues that have become a recurrent theme in the FDA’s inspection of Indian facilities.

The other was the inspector’s repeated use of the world ‘collaborative.’ We will work with you on this, was the message. If you’ve goofed up, let us know, and we will give you an opportunity to correct.

Since then, another of Arch’s facilities, dubbed Vitalife, has also been successfully inspected. This one did export to the US. Unlike before, it was not one but two inspectors who worked in tandem.

Key takeaways

I am yet to come to terms with the fact that we now have an unfactored additional FDA-inspected unit. I thought it only fair that I share this with my colleagues in the industry who might not be aware that even SIN applications can trigger inspections.

Besides, I would like to point out that the FDA has been the most benign of all the regulatory agencies that we have interacted with from the highly-regulated markets. The inspector gives you the day’s report card and takes cognizance of the changes you’ve made the next day. It is not the monster it is made out to be.

If we fail inspections, we have ourselves to blame. Indian companies must come up to speed and stop expecting the luxury of a 90-day notice for inspection.

Also, watch out for overenthusiastic colleagues with SIN on their minds!

Ajit Kamath , 46, is the Chairman & Managing Director of Arch Pharmalabs Limited. Arch, founded by Kamath in 1999, manufactures intermediates and active pharmaceutical ingredients for innovator and generic companies globally.  Arch facilities have been inspected by a number of global regulatory agencies such as US FDA, EDQM, TGA, PMDA,  and WHO-Geneva.


7 thoughts on “Guest column : The ‘sin’ that led to an #FDA inspection #pharma #quality

    1. Thanks for writing in Anup. It is through such proactive contributors as Ajit Kamath that Apothecurry hopes to add value to the narrative of Indian pharma. (I might add here that you have been one yourself!)


  1. every damn Indian company knows fact about their quality and that’s why they blame USFDA and lobby against it. Thank god, someone came in support in open.


  2. With due respect to the USFDA regulations , Certifications , Indian Pharma companies, it’s unfortunate to see the increasing trends and threats on import bans from US. I think Indian Pharma Industry needs to seriously work towards image makeover & achieve the vision and mission of “Make In India “.


  3. Glad to hear about the positive experience and most importantly the EIR. Also – First, the positive experience here bodes well for the future when there is true parity as intended by GDUFA (note that renewal of GDUFA is coming up in 2017) when there are no prior announcements or warnings of an inspection as is the tradition in the U.S. Second, this should serve as a reminder to companies seeking facility identification numbers that GDUFA was designed to weed out companies that never had any interest in entering the US market (directly or as a supplier). Note that the more companies that remain on the FEI, this also has the negative impact on the generic sector when USFDA calculates their user fees under GDUFA…


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