Consumer Product Partners, LLC
Form 483 issued October 13, 2021 · St. Louis, Missouri
- Inspection
- Oct 4 – Oct 13, 2021
- Investigators
- Matthew Schuckmann· Robert J. Ham
- Observations
- 6
- Pages
- 6
- FEI number
- 1941150
In short: On October 13, 2021, FDA issued a Form 483 with 6 observations to Consumer Product Partners, LLC in St. Louis, Missouri (FEI 1941150) after an inspection that ran Oct 4 – Oct 13, 2021. The investigators were Matthew Schuckmann and Robert J. Ham. Most observations concern quality system and materials; the most-cited regulation is 21 CFR 211.80 (general requirements).
At a glance
Quality system and materials account for 4 of 6 observations.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Written procedures are not followed for the handling, sampling…
- 02
Procedures designed to prevent objectionable microorganisms in drug products not required to be sterile are not…
- 03
Appropriate controls are not exercised over computers or related systems to assure that changes in master…
- 04
The responsibilities and procedures applicable to the quality unit are not in…
This inspection in context
Matthew Schuckmann
7 documents · 2021–2026
Cites 211.22 (responsibilities of quality control unit) 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 211.80
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Consumer Product Partners, LLC?
FDA listed 6 observations on this Form 483, mostly about quality system, materials and production. The most-cited regulation is 21 CFR 211.80 (general requirements). The opening words of each observation are shown on this page.
Who inspected Consumer Product Partners, LLC?
Matthew Schuckmann and Robert J. Ham are named on this Form 483, for the inspection of Oct 4 – Oct 13, 2021. Each investigator has a profile showing what they cite most.
When was Consumer Product Partners, LLC inspected by FDA?
The inspection ran Oct 4 – Oct 13, 2021, and the Form 483 is dated October 13, 2021.
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.