Consumer Product Partners, LLC
Form 483 issued June 14, 2023 · St. Louis, Missouri
- Inspection
- Jun 5 – Jun 14, 2023
- Investigators
- Monica E. Murie· Robert J. Ham
- Observations
- 4
- Pages
- 8
- FEI number
- 1941150
In short: On June 14, 2023, FDA issued a Form 483 with 4 observations to Consumer Product Partners, LLC in St. Louis, Missouri (FEI 1941150) after an inspection that ran Jun 5 – Jun 14, 2023. The investigators were Monica E. Murie and Robert J. Ham. Most observations concern quality system and production.
At a glance
Quality system and production account for 3 of 4 observations.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Procedures designed to prevent objectionable microorganisms in drug products not required to be sterile are not…
- 02
There is a failure to thoroughly review any unexplained discrepancy whether or not the batch…
- 03
The responsibilities and procedures applicable to the quality unit are not in…
- 04
Written procedures are not followed for the handling, sampling…
This inspection in context
Monica E. Murie
11 documents · 2022–2025
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in Missouri.
The firmConsumer Product Partners, LLC history
All 4 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.113
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Consumer Product Partners, LLC?
FDA listed 4 observations on this Form 483, mostly about quality system, production and materials. The opening words of each observation are shown on this page.
Who inspected Consumer Product Partners, LLC?
Monica E. Murie and Robert J. Ham are named on this Form 483, for the inspection of Jun 5 – Jun 14, 2023. Each investigator has a profile showing what they cite most.
When was Consumer Product Partners, LLC inspected by FDA?
The inspection ran Jun 5 – Jun 14, 2023, and the Form 483 is dated June 14, 2023.
How do I get the full Form 483 for Consumer Product Partners, 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.