| 00:00 - 00:03 | It was a spot audit by the FDA |
| 00:04 - 00:05 | Nobody knew they were coming |
| 00:05 - 00:07 | The first site was here in Berlin |
| 00:08 - 00:12 | There were 3 of them and they would not take no for an answer |
| 00:12 - 00:15 | and they insisted on Starbucks coffee and doughnuts from here. |
| 00:17 - 00:19 | The FDA do not bother me. |
| 00:19 - 00:21 | Everything is well hidden. |
| 00:24 - 00:26 | Boss... |
| 00:27 - 00:28 | I... |
| 00:31 - 00:33 | The idiot did not fake the consent forms. |
| 00:34 - 00:36 | All 200 subjects did not sign an IRB approved consent |
| 00:53 - 00:58 | Everyone that has no clue what we are talking about leave the room. |
| 01:13 - 01:15 | You fucking retards |
| 01:15 - 01:17 | Everyone knows that we have to use the correct forms |
| 01:18 - 01:23 | I bet the FDA had their stupid little notebooks and wrote everything down |
| 01:25 - 01:28 | How difficult can it be? |
| 01:29 - 01:31 | Now the Sponsor will hear about it |
| 01:31 - 01:34 | We are unmonitored, they wouldn't have known |
| 01:34 - 01:37 | It would have been easy you fuckers |
| 01:37 - 01:40 | Tell me those FDA fuckwits didn't notice... |
| 01:40 - 01:42 | Unfotunately they issued us with a 483 |
| 01:42 - 01:46 | A fucking 483? You moron! |
| 01:46 - 01:48 | Boss, we didn't know they were coming |
| 01:48 - 01:52 | I asked you fucking weeks ago to get rid of those forms |
| 01:53 - 01:54 | Why didn't you just tipex out the version? |
| 01:56 - 01:57 | Better still, you could have binned them |
| 01:57 - 02:00 | and just printed new ones |
| 02:00 - 02:03 | No one would have been any the wiser |
| 02:04 - 02:08 | Now i have to pansy around the FDA |
| 02:08 - 02:13 | and write them some shitty letter begging their holy forgiveness |
| 02:14 - 02:16 | I hate the fucking FDA |
| 02:17 - 02:21 | Acting like the world police with their clipboards and black pens |
| 02:27 - 02:29 | They don't even recognise The Declaration of Helsinki |
| 02:30 - 02:34 | Things are different here, we like decent coffee |
| 02:34 - 02:36 | and hate Starbucks cat urine |
| 02:41 - 02:42 | A fucking 483? I ask you... |
| 02:43 - 02:47 | Well you lot can fucking sort it out. I am not. |
| 02:48 - 02:53 | If you think i'm starting a CAPA on a Friday... |
| 02:54 - 02:56 | I hate that fucking CAPA system |
| 02:56 - 02:59 | I can't even remember my password. |
| 03:00 - 03:02 | I wrote it down, but now can't find it. |
| 03:04 - 03:07 | You didn't know, you're safe... |
| 03:14 - 03:16 | All you had to do was fake some forms... |
| 03:19 - 03:23 | ... and burn the old ones... |
| 03:25 - 03:26 | ...fuckwits. |
| 03:31 - 03:33 | We are fucked. |
| 03:40 - 03:46 | We will have to reconsent everyone. There is no way to hide it now. |
| 03:46 - 03:49 | I may as well cancel my holiday |
| 03:53 - 03:56 | You are all fired. |
