PD-Rx Pharmaceuticals, Inc
Form 483 issued November 10, 2022 · Oklahoma City, Oklahoma
- Inspection
- Nov 1 – Nov 10, 2022
- Investigators
- Christopher N. Tran· Dorothy P. Kramer· Margaret M. Annes
- Observations
- 5
- Pages
- 5
- FEI number
- 1641825
In short: On November 10, 2022, FDA issued a Form 483 with 5 observations to PD-Rx Pharmaceuticals, Inc in Oklahoma City, Oklahoma (FEI 1641825) after an inspection that ran Nov 1 – Nov 10, 2022. The investigators were Christopher N. Tran, Dorothy P. Kramer and Margaret M. Annes. Most observations concern quality system and production; the most-cited regulation is 21 CFR 211.100 (written procedures; deviations).
At a glance
Quality system and production account for 4 of 5 observations.
Most cited: 21 CFR 211.100(a) (2×)
What FDA observed
Preview: the opening words of each observation- 01
The responsibilities and procedures applicable to the quality control unit are not in…
- 02
Changes to written procedures are not drafted, reviewed and approved by the appropriate organizational unit and…
- 03
Employees engaged in the manufacture, processing, packing and holding of a drug product lack the training…
- 04
Your firm failed to establish adequate written procedures for production and process controls designed to assure…
This inspection in context
Christopher N. Tran
3 documents · 2022–2023
Cites 211.42(a) (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 211.100(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 5 observations on this Form 483, mostly about quality system, production and facilities & equipment. The most-cited regulation is 21 CFR 211.100 (written procedures; deviations). The opening words of each observation are shown on this page.
Who inspected PD-Rx Pharmaceuticals, Inc?
Christopher N. Tran, Dorothy P. Kramer and Margaret M. Annes are named on this Form 483, for the inspection of Nov 1 – Nov 10, 2022. Each investigator has a profile showing what they cite most.
When was PD-Rx Pharmaceuticals, Inc inspected by FDA?
The inspection ran Nov 1 – Nov 10, 2022, and the Form 483 is dated November 10, 2022.
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.