OSI Batteries, LLC
Form 483 issued October 28, 2024 · Minnetonka, Minnesota
- Inspection
- Oct 24 – Oct 28, 2024
- Investigator
- Albert L. Nguyen
- Observations
- 2
- Pages
- 4
- FEI number
- 2183890
In short: On October 28, 2024, FDA issued a Form 483 with 2 observations to OSI Batteries, LLC in Minnetonka, Minnesota (FEI 2183890) after an inspection that ran Oct 24 – Oct 28, 2024. The investigator was Albert L. Nguyen. Most observations concern production & process controls and management controls; the most-cited regulation is 21 CFR 820.70 (production and process controls).
At a glance
Production & process controls and management controls account for 2 of 2 observations.
Most cited: 21 CFR 820.70(a) (1×) · 820.22 (1×)
What FDA observed
Preview: the opening words of each observation- 01
Process control procedures that describe any process controls necessary to ensure conformance to specifications have…
- 02
Quality audits have not…
This inspection in context
Albert L. Nguyen
4 documents · 2020–2024
Cites 820.70(a) (production and process controls) more than any other section. Most of their documents are for sites in Minnesota.
The firmOSI Batteries, LLC history
The site's inspection history, in date order.
Similar 483sOther sites cited under 820.70(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at OSI Batteries, LLC?
FDA listed 2 observations on this Form 483, mostly about production & process controls and management controls. The most-cited regulation is 21 CFR 820.70 (production and process controls). The opening words of each observation are shown on this page.
Who inspected OSI Batteries, LLC?
Albert L. Nguyen is named on this Form 483, for the inspection of Oct 24 – Oct 28, 2024. Each investigator has a profile showing what they cite most.
When was OSI Batteries, LLC inspected by FDA?
The inspection ran Oct 24 – Oct 28, 2024, and the Form 483 is dated October 28, 2024.
How do I get the full Form 483 for OSI Batteries, 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.