Northern Labs, Inc.
Form 483 issued February 6, 2025 · Manitowoc, Wisconsin
- Investigator
- Tyler Peterson
- Observations
- 2
- Pages
- 3
- FEI number
- 2121746
In short: On February 6, 2025, FDA issued a Form 483 with 2 observations to Northern Labs, Inc. in Manitowoc, Wisconsin (FEI 2121746). The investigator was Tyler Peterson. Most observations concern materials and quality system; the most-cited regulation is 21 CFR 211.84 (testing and approval or rejection of components, drug product containers, and closures).
At a glance
Materials and quality system account for 2 of 2 observations.
Most cited: 21 CFR 211.84(d)(6) (1×) · 211.22(d) (1×)
What FDA observed
Preview: the opening words of each observation- 01
Each lot of a component liable to objectionable microbiological contamination is deficiently subjected to…
- 02
The responsibilities and procedures applicable to the quality control unit…
This inspection in context
Tyler Peterson
10 documents · 2024–2026
Cites 211.67 (equipment cleaning and maintenance) more than any other section. Most of their documents are for sites in Illinois.
The firmNorthern Labs, Inc. history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.84(d)(6)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Northern Labs, Inc.?
FDA listed 2 observations on this Form 483, mostly about materials and quality system. The most-cited regulation is 21 CFR 211.84 (testing and approval or rejection of components, drug product containers, and closures). The opening words of each observation are shown on this page.
Who inspected Northern Labs, Inc.?
Tyler Peterson is named on this Form 483. Each investigator has a profile showing what they cite most.
When was Northern Labs, Inc. inspected by FDA?
This Form 483 is dated February 6, 2025.
How do I get the full Form 483 for Northern Labs, 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.