Medcraft, LLC
Form 483 issued July 27, 2018 · Mounds, Oklahoma
- Inspection
- May 14 – Jul 27, 2018
- Investigator
- Margaret M. Annes
- Observations
- 1
- Pages
- 1
- FEI number
- 3013329127
In short: On July 27, 2018, FDA issued a Form 483 with 1 observation to Medcraft, LLC in Mounds, Oklahoma (FEI 3013329127) after an inspection that ran May 14 – Jul 27, 2018. The investigator was Margaret M. Annes. Most observations concern facilities & equipment; the most-cited regulation is 21 CFR 211.42 (design and construction features).
At a glance
1 of 1 observations on this 483 concern facilities & equipment.
Most cited: 21 CFR 211.42(c)(10)(v) (1×)
What FDA observed
Preview: the opening words of each observation- 01
Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the room and equipment…
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 firmMedcraft, LLC history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.42(c)(10)(v)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Medcraft, LLC?
FDA listed 1 observation on this Form 483, mostly about facilities & equipment. The most-cited regulation is 21 CFR 211.42 (design and construction features). The opening words of each observation are shown on this page.
Who inspected Medcraft, LLC?
Margaret M. Annes is named on this Form 483, for the inspection of May 14 – Jul 27, 2018. Each investigator has a profile showing what they cite most.
When was Medcraft, LLC inspected by FDA?
The inspection ran May 14 – Jul 27, 2018, and the Form 483 is dated July 27, 2018.
How do I get the full Form 483 for Medcraft, 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.