3 replies to this topic

[santa2023]

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. 

 

[acarver]

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

[TimG]

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.

[MDaleDDF]

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....