Specialty Formulations and Manufacturing LLC
Form 483 issued February 20, 2019 · Phoenix, Arizona
- Inspection
- Jan 30 – Feb 20, 2019
- Investigator
- Cncopner A. Emer
- Observations
- 7
- Pages
- 6
- FEI number
- 3008274683
In short: On February 20, 2019, FDA issued a Form 483 with 7 observations to Specialty Formulations and Manufacturing LLC in Phoenix, Arizona (FEI 3008274683) after an inspection that ran Jan 30 – Feb 20, 2019. The investigator was Cncopner A. Emer. Most observations concern laboratory controls and production.
At a glance
Observations span 4 systems, led by laboratory controls.
What FDA observed
Preview: the opening words of each observation- 01
Testing and release of drug product for distribution do not include appropriate laboratory determination of satisfactory…
- 02
There is no written testing program designed to assess the stability…
- 03
Each component is not tested for conformity with all appropriate written specifications for…
- 04
There is no quality…
This inspection in context
Cncopner A. Emer
1 document · 2019
Cites 211.100(a) (written procedures; deviations) more than any other section. Most of their documents are for sites in Arizona.
The firmSpecialty Formulations and Manufacturing LLC history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.165(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Specialty Formulations and Manufacturing LLC?
FDA listed 7 observations on this Form 483, mostly about laboratory controls, production and materials. The opening words of each observation are shown on this page.
Who inspected Specialty Formulations and Manufacturing LLC?
Cncopner A. Emer is named on this Form 483, for the inspection of Jan 30 – Feb 20, 2019. Each investigator has a profile showing what they cite most.
When was Specialty Formulations and Manufacturing LLC inspected by FDA?
The inspection ran Jan 30 – Feb 20, 2019, and the Form 483 is dated February 20, 2019.
How do I get the full Form 483 for Specialty Formulations and Manufacturing 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.