DA BOMB LLC
Form 483 issued May 5, 2025 · Minneapolis, Minnesota
- Inspection
- May 1 – May 5, 2025
- Investigators
- Elizabeth R. Bloom· Soyinka S. Eneng
- Observations
- 4
- Pages
- 4
- FEI number
- 3014647198
In short: On May 5, 2025, FDA issued a Form 483 with 4 observations to DA BOMB LLC in Minneapolis, Minnesota (FEI 3014647198) after an inspection that ran May 1 – May 5, 2025. The investigators were Elizabeth R. Bloom and Soyinka S. Eneng. Most observations concern quality system and materials.
At a glance
Observations span 4 systems, led by quality system.
What FDA observed
Preview: the opening words of each observation- 01
There is no quality…
- 02
The identity of each component of a drug product is not verified by conducting at least…
- 03
Testing and release of drug product for distribution do not include appropriate laboratory determination of satisfactory…
- 04
Your firm failed to establish written procedures for production and process controls designed to assure that…
This inspection in context
Elizabeth R. Bloom
2 documents · 2024–2025
Cites 211.22(a) (responsibilities of quality control unit) more than any other section. Most of their documents are for sites in Kentucky.
The firmDA BOMB LLC history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.22(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at DA BOMB LLC?
FDA listed 4 observations on this Form 483, mostly about quality system, materials and laboratory controls. The opening words of each observation are shown on this page.
Who inspected DA BOMB LLC?
Elizabeth R. Bloom and Soyinka S. Eneng are named on this Form 483, for the inspection of May 1 – May 5, 2025. Each investigator has a profile showing what they cite most.
When was DA BOMB LLC inspected by FDA?
The inspection ran May 1 – May 5, 2025, and the Form 483 is dated May 5, 2025.
How do I get the full Form 483 for DA BOMB 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.