Signature Formulations LLC
Form 483 issued November 22, 2023 · Phoenix, Arizona
- Inspection
- Nov 14 – Nov 22, 2023
- Observations
- 6
- Pages
- 7
- FEI number
- 3011368010
In short: On November 22, 2023, FDA issued a Form 483 with 6 observations to Signature Formulations LLC in Phoenix, Arizona (FEI 3011368010) after an inspection that ran Nov 14 – Nov 22, 2023. Most observations concern laboratory controls and quality system.
At a glance
Laboratory controls and quality system account for 5 of 6 observations.
What FDA observed
Preview: the opening words of each observation- 01
Your firm failed to establish written procedures for production and process controls designed to assure that…
- 02
Testing and release of drug product for distribution do not include appropriate laboratory determination of satisfactory…
- 03
The written stability testing…
- 04
There is no quality…
This inspection in context
Questions about this 483
What did FDA find at Signature Formulations LLC?
FDA listed 6 observations on this Form 483, mostly about laboratory controls, quality system and production. The opening words of each observation are shown on this page.
When was Signature Formulations LLC inspected by FDA?
The inspection ran Nov 14 – Nov 22, 2023, and the Form 483 is dated November 22, 2023.
How do I get the full Form 483 for Signature Formulations LLC?
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.