Dynamic Blending Specialists, Inc.
Form 483 issued December 6, 2024 · Vineyard, Utah
- Inspection
- Dec 3 – Dec 6, 2024
- Observations
- 6
- Pages
- 7
- FEI number
- 3013719300
In short: On December 6, 2024, FDA issued a Form 483 with 6 observations to Dynamic Blending Specialists, Inc. in Vineyard, Utah (FEI 3013719300) after an inspection that ran Dec 3 – Dec 6, 2024. Most observations concern materials and laboratory controls; the most-cited regulation is 21 CFR 211.84 (testing and approval or rejection of components, drug product containers, and closures).
At a glance
Materials and laboratory controls account for 4 of 6 observations.
What FDA observed
Preview: the opening words of each observation- 01
Each lot of components is not withheld from use until the lot has been sampled, tested…
- 02
Reports of analysis from component suppliers are accepted in lieu of testing each component for conformity…
- 03
The responsibilities and procedures applicable to the quality control unit are not in…
- 04
There is no written testing program designed to assess the stability characteristics of…
This inspection in context
Questions about this 483
What did FDA find at Dynamic Blending Specialists, Inc.?
FDA listed 6 observations on this Form 483, mostly about materials, laboratory controls and quality system. The most-cited regulation is 21 CFR 211.84 (testing and approval or rejection of components, drug product containers, and closures). The opening words of each observation are shown on this page.
When was Dynamic Blending Specialists, Inc. inspected by FDA?
The inspection ran Dec 3 – Dec 6, 2024, and the Form 483 is dated December 6, 2024.
How do I get the full Form 483 for Dynamic Blending Specialists, Inc.?
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.