Quality CDMO
Form 483 issued June 16, 2023 · Fort Worth, Texas
- Observations
- 3
- Pages
- 4
- FEI number
- 3017569510
In short: On June 16, 2023, FDA issued a Form 483 with 3 observations to Quality CDMO in Fort Worth, Texas (FEI 3017569510). Most observations concern production and quality system.
At a glance
2 of 3 observations on this 483 concern production.
What FDA observed
Preview: the opening words of each observation- 01
Control procedures are not established which monitor the output and validate the performance of those manufacturing…
- 02
The quality control unit lacks the responsibility and authority to approve and reject all…
- 03
Time limits are not established when appropriate for the completion of each production phase to assure…
This inspection in context
Questions about this 483
What did FDA find at Quality CDMO?
FDA listed 3 observations on this Form 483, mostly about production and quality system. The opening words of each observation are shown on this page.
When was Quality CDMO inspected by FDA?
This Form 483 is dated June 16, 2023.
How do I get the full Form 483 for Quality CDMO?
Download the original PDF from FDA Intel for $99, with no subscription. Your first Form 483 or letter is on us. You also get an invoice PDF with the order.