FDA Form 483 Resilience US, Inc. Durham, NC, Feb 2024
Form 483 · Inc. Durham, North Carolina
- Observations
- 5
- Pages
- 1
In short: FDA issued a Form 483 with 5 observations to FDA Form 483 Resilience US, Inc. Durham, NC, Feb 2024 in Inc. Durham, North Carolina.
What FDA observed
Preview: the opening words of each observation- 01
Inadequate procedures to classify events as deviations. Appendix 1 of D-00694, Global Deviation Management, contains a…
- 02
Defined procedures for retesting for Out of…
- 03
Inadequate procedures to trend…
- 04
The disinfectant efficacy study…
This inspection in context
Questions about this 483
What did FDA find at FDA Form 483 Resilience US, Inc. Durham, NC, Feb 2024?
FDA listed 5 observations on this Form 483. The opening words of each observation are shown on this page.
How do I get the full Form 483 for FDA Form 483 Resilience US, Inc. Durham, NC, Feb 2024?
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.