McAlister Drug Corporation
Form 483 issued October 3, 2019 · Yukon, Oklahoma
- Inspection
- Sep 23 – Oct 3, 2019
- Investigators
- Margaret M. Annes· Shanna N. Purdy
- Observations
- 6
- Pages
- 5
- FEI number
- 3012906298
In short: On October 3, 2019, FDA issued a Form 483 with 6 observations to McAlister Drug Corporation in Yukon, Oklahoma (FEI 3012906298) after an inspection that ran Sep 23 – Oct 3, 2019. The investigators were Margaret M. Annes and Shanna N. Purdy. Most observations concern laboratory controls and facilities & equipment.
At a glance
Observations span 3 systems, led by laboratory controls.
Most cited: FDCA 501(a)(2)(A) (2×)
What FDA observed
Preview: the opening words of each observation- 01FDCA 501(a)(2)(A)
You used a non-pharmaceutical grade component in the formulation…
- 02FDCA 501(a)(2)(A)
You produced hazardous drugs without providing adequate cleaning of work surfaces and clean ing of…
- 03
There is no written testing program designed to assess the stability…
- 04
EM PLOYEE(S) SIGNATURE Testing and release of drug product for distribution do not include appropriate laboratory…
This inspection in context
Margaret M. Annes
60 documents · 2007–2026
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in Texas.
The firmMcAlister Drug Corporation history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.166(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at McAlister Drug Corporation?
FDA listed 6 observations on this Form 483, mostly about laboratory controls, facilities & equipment and production. The opening words of each observation are shown on this page.
Who inspected McAlister Drug Corporation?
Margaret M. Annes and Shanna N. Purdy are named on this Form 483, for the inspection of Sep 23 – Oct 3, 2019. Each investigator has a profile showing what they cite most.
When was McAlister Drug Corporation inspected by FDA?
The inspection ran Sep 23 – Oct 3, 2019, and the Form 483 is dated October 3, 2019.
How do I get the full Form 483 for McAlister Drug Corporation?
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.