MPP PHARMA LLC
Form 483 issued April 21, 2021 · Kansas City, Missouri
- Inspection
- Apr 12 – Apr 21, 2021
- Investigators
- Carl A. Huffman· Torrey M. Ward
- Observations
- 2
- Pages
- 4
- FEI number
- 1930436
In short: On April 21, 2021, FDA issued a Form 483 with 2 observations to MPP PHARMA LLC in Kansas City, Missouri (FEI 1930436) after an inspection that ran Apr 12 – Apr 21, 2021. The investigators were Carl A. Huffman and Torrey M. Ward. Most observations concern quality system and production; the most-cited regulation is 21 CFR 211.192 (production record review).
At a glance
Quality system and production account for 2 of 2 observations.
Most cited: 21 CFR 211.192 (1×) · 211.100(b) (1×)
What FDA observed
Preview: the opening words of each observation- 01
Investigations of a failure of a batch or any of its components to meet any of…
- 02
Written production and process control procedures are not followed in the execution of production and process…
This inspection in context
Carl A. Huffman
11 documents · 2015–2026
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in Kansas.
The firmMPP PHARMA LLC history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.192
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at MPP PHARMA LLC?
FDA listed 2 observations on this Form 483, mostly about quality system and production. The most-cited regulation is 21 CFR 211.192 (production record review). The opening words of each observation are shown on this page.
Who inspected MPP PHARMA LLC?
Carl A. Huffman and Torrey M. Ward are named on this Form 483, for the inspection of Apr 12 – Apr 21, 2021. Each investigator has a profile showing what they cite most.
When was MPP PHARMA LLC inspected by FDA?
The inspection ran Apr 12 – Apr 21, 2021, and the Form 483 is dated April 21, 2021.
How do I get the full Form 483 for MPP PHARMA 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.