PD-Rx Pharmaceuticals, Inc
Form 483 issued December 4, 2015 · Oklahoma City, Oklahoma
- Inspection
- Dec 1 – Dec 4, 2015
- Investigators
- Margaret M. Annes· Shawn E. Larson
- Observations
- 6
- Pages
- 4
- FEI number
- 1641825
In short: On December 4, 2015, FDA issued a Form 483 with 6 observations to PD-Rx Pharmaceuticals, Inc in Oklahoma City, Oklahoma (FEI 1641825) after an inspection that ran Dec 1 – Dec 4, 2015. The investigators were Margaret M. Annes and Shawn E. Larson. Most observations concern quality system and facilities & equipment.
At a glance
Observations span 4 systems, led by quality system.
What FDA observed
Preview: the opening words of each observation- 01
Procedures describing the handling of written and oral complaints related to drug products are…
- 02
Equipment used in the manufacture, processing, packing or holding of drug products is not of appropriate…
- 0321 CFR 211.25(a)21 CFR 210
Employees engaged in the manufacture and processing and packing and holding of a drug product lack…
- 04
There is no written testing program designed to assess the stability…
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 firmPD-Rx Pharmaceuticals, Inc history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.198(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at PD-Rx Pharmaceuticals, Inc?
FDA listed 6 observations on this Form 483, mostly about quality system, facilities & equipment and laboratory controls. The opening words of each observation are shown on this page.
Who inspected PD-Rx Pharmaceuticals, Inc?
Margaret M. Annes and Shawn E. Larson are named on this Form 483, for the inspection of Dec 1 – Dec 4, 2015. Each investigator has a profile showing what they cite most.
When was PD-Rx Pharmaceuticals, Inc inspected by FDA?
The inspection ran Dec 1 – Dec 4, 2015, and the Form 483 is dated December 4, 2015.
How do I get the full Form 483 for PD-Rx Pharmaceuticals, Inc?
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.