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What happened after an FDA inspection?

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santa2023

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Posted Yesterday, 11:38 PM

Hello everyone,

 

Our warehouse was visited by an FDA consumer safety officer (investigator) near the end of 2025. During the inspection, the investigator reviewed our GMP documentation, provided comments on several facility infrastructure issues, and asked us to dispose of products past their best-before dates in a more timely manner.

 

At the beginning of the inspection, the inspector gave us Form FDA 482 (dated 9/11). The investigator indicated that an inspection report would be emailed to us, but we never received one. We would like to confirm whether the FDA still issues formal inspection reports via email, or if inspection outcomes are now only posted periodically to the FDA online database (https://datadashboar...inspections.htm)

 

Also, should we expect a follow-up inspection? For future inspections, should we request a closing report or written summary at the end of the inspection right away?

 

Thank you in advance! We are very new to the US distribution business. 

 


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acarver

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Posted Today, 12:53 PM

After my last FDA inspection, it took almost 6 months to receive the report. 


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TimG

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Posted Today, 01:51 PM

I had 2 FDA inspections last year, both performed by MDARD (contracted for FDA). I received both reports within 1 week of the associated inspection. They also said FDA is extremely behind, so if yours was done by FDA proper, that might be why it's taking so long to get the report.


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MDaleDDF

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Posted Today, 01:54 PM

Is it me or is everyone getting like this nowadays?   I just had my scale people come in.   I had to chase them around for a week to finally get my validation paperworks.   I've been emailing my metal detector guy for months trying to get him here for paperwork/training that we do every year, with this same guy, at least the last 20 years.   First time he's scheduled (my whole team sitting here getting paid and waiting for him) he doesn't show, doesn't call.    I finally track him down and "he forgot".    Two weeks later finally get him here.     My FSSC audit results took two months to receive.

It seems like everyone has gone nuts.   Ever seen The Gods Must Be Crazy?     That's what the food biz feels like lately....


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GMO

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Posted 37 minutes ago

Is it me or is everyone getting like this nowadays?   I just had my scale people come in.   I had to chase them around for a week to finally get my validation paperworks.   I've been emailing my metal detector guy for months trying to get him here for paperwork/training that we do every year, with this same guy, at least the last 20 years.   First time he's scheduled (my whole team sitting here getting paid and waiting for him) he doesn't show, doesn't call.    I finally track him down and "he forgot".    Two weeks later finally get him here.     My FSSC audit results took two months to receive.

It seems like everyone has gone nuts.   Ever seen The Gods Must Be Crazy?     That's what the food biz feels like lately....

 

Not just food. Everything.

 

I needed to return an Amazon parcel yesterday. I assume you have the same there that you can just drop it off at a locker. Walked there, figured I'd get my steps in. 7pm last night. Snowing. Get there and the QR code doesn't work. Cancel the return, start it again. Same. Call them up, they tell me not to worry returning and they'll refund. Walk back in snow. Today. Still showing as "need to return item". Call again. Very sorry. We will refund you this time. Still nothing.

I swear it's a combination of employees having a very different attitude to work and work ethic which was changed by the pandemic but also an attitude of some companies that they will see what they can get away with.

I'm old. If I say I'll do something by x date, it will be done. But not to make this into a "all Millennials and Gen Z are bad" post because it's not just them. Everyone just seems to care a bit less about being conscientious. 


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