Warning letter

ProRx LLC: warning letter of Apr 7, 2026

FDA warning letter 723704 · Center for Drug Evaluation and Research (CDER)

Key facts

Reference number 723704
Company ProRx LLC
Subject Compounding Pharmacy/Adulterated Drug Products
Issue date Apr 7, 2026
Posted date May 12, 2026
Issuing office Center for Drug Evaluation and Research (CDER)
Product type Drugs
CFR sections cited 200.10(b), 201.115, 210.1(b), 211.22(c), 211.42(c)(10)(iv), 211.42(c)(10)(v), 211.113(b), 211.192, 310.305(c)(2), 310.305(b)
Inspection city Exton
Inspection ZIP 19341
Inspection start date Sep 9, 2025
Letter on fda.gov fda.gov

At a glance

  • 10–99 CFR sections cited
  • OAI Linked inspection classification
  • Yes Form FDA 483 issued

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About FDA warning letters

FDA warning letters notify a firm of significant regulatory violations found during an inspection or review and request prompt corrective action.

Source: U.S. Food and Drug Administration (FDA), Warning Letters · Source date:

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