Bioequivalence and Bioavailability Forum • Dates

Dates [GxP / QC / QA]

posted by Ohlbe – France, 2021-09-17 12:15 (803 d 08:00 ago) – Posting: # 22579
Views: 5,064

Dear ElMaestro,

❝ Have a look at the pdf files from FDA. Now answer this question: Which day were the letters issued?

Well, the only place where you can find a date is the name of the PDF file, which for both letters includes "9.15.21". If you were to tell an FDA inspector this is how you date your documents, you would get his autograph on a '483.

By the way, I forgot. Look at the date of the inspection on Synchron's letter. Now look at this announcement on their web site :-D

—
Regards
Ohlbe

Complete thread:

Another two... Ohlbe 2021-09-16 23:41 [GxP / QC / QA]
- Another two... ElMaestro 2021-09-17 08:42
  - DatesOhlbe 2021-09-17 10:15
  - Some more info Ohlbe 2021-09-17 20:28
    - EU Article 31 referral started Ohlbe 2022-01-24 17:47
- Cheating Helmut 2021-09-17 16:50
  - Increased variability Ohlbe 2021-09-17 17:56
    - Increased variability ElMaestro 2021-09-17 18:51
      - Visualization Helmut 2021-09-18 15:26
- Another two... jag009 2021-09-19 09:18
- Another two... ElMaestro 2022-05-24 12:00
  - Blind monitors or greedy sponsors? Helmut 2022-05-24 12:51
    - Blind monitors or greedy sponsors? Ohlbe 2022-05-24 14:21
      - Blind monitors or greedy sponsors? Helmut 2022-05-24 16:35
    - Blind monitors or greedy sponsors? ElMaestro 2022-05-25 08:11
      - (Cumulative) T/R-ratio vs. time Helmut 2022-05-25 09:19
        
        Sponsors and CRO selection Ohlbe 2022-05-25 10:53
        
        I still think that T/R-ratios are useful Helmut 2022-05-25 12:04
        
        T/R-ratios are useful Ohlbe 2022-05-25 14:40
        
        T/R-ratios are useful Helmut 2022-05-25 15:35
        Bust the Buster Helmut 2022-05-26 15:32
        
        complicate the assessor's life mittyri 2022-05-26 18:28
        
        complicate the assessor's life PharmCat 2022-05-27 09:57
        complicate the assessor's life Helmut 2022-05-27 10:11
        
        Thanks for Busting the Buster sameep 2022-05-31 08:34
        
        Thanks for Busting the Buster Helmut 2022-05-31 15:22
        
        A small point for the code sameep 2022-06-01 13:17
        
        A small point for the code Helmut 2022-06-01 14:11