Physician Preferred Medical, LLC
Form 483 issued February 19, 2015 · Oklahoma City, Oklahoma
- Inspection
- Feb 3 – Feb 19, 2015
- Investigators
- Lloyd D. Payne· Margaret M. Annes
- Observations
- 18
- Pages
- 7
- FEI number
- 3011278953
In short: On February 19, 2015, FDA issued a Form 483 with 18 observations to Physician Preferred Medical, LLC in Oklahoma City, Oklahoma (FEI 3011278953) after an inspection that ran Feb 3 – Feb 19, 2015. The investigators were Lloyd D. Payne and Margaret M. Annes. Most observations concern facilities & equipment and production; the most-cited regulation is 21 CFR 211.42 (design and construction features).
At a glance
Facilities & equipment and production account for 11 of 18 observations.
Most cited: 21 CFR 211.42 (2×) · 211.94 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
The separate or defined areas and control systems necessary to prevent contamination…
- 02
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile do not include…
- 03
There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch…
- 04
Written procedures are not established for the cleaning and maintenance of equipment, including utensils, used in…
This inspection in context
Lloyd D. Payne
3 documents · 2015
Cites 110.80 (processes and controls) more than any other section. Most of their documents are for sites in Oklahoma.
The firmPhysician Preferred Medical, LLC history
All 3 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.42
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Physician Preferred Medical, LLC?
FDA listed 18 observations on this Form 483, mostly about facilities & equipment, production and laboratory controls. 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 Physician Preferred Medical, LLC?
Lloyd D. Payne and Margaret M. Annes are named on this Form 483, for the inspection of Feb 3 – Feb 19, 2015. Each investigator has a profile showing what they cite most.
When was Physician Preferred Medical, LLC inspected by FDA?
The inspection ran Feb 3 – Feb 19, 2015, and the Form 483 is dated February 19, 2015.
How do I get the full Form 483 for Physician Preferred Medical, 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.