Out Of The Shell, LLC FDA Record

Summary

FDA record by year

Out Of The Shell, LLC's FDA inspections, warning letters and recalls in each of the last 10 calendar years (2017 to 2026, 2026 so far).

Inspections are counted by the date they ended, warning letters by the date FDA issued them and recall records by the recall start date. FDA lists one recall record per recalled product, so one recall event can add several.

Recent FDA inspections

2 inspections from May 1, 2025 to Apr 16, 2026.

NAI

No objectionable conditions or practices were found during the inspection.

VAI

Objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action.

OAI

Regulatory and/or administrative actions are recommended.

Look up the inspector observations behind these results with the FDA 483 search, or check for formal enforcement with the FDA warning letter search.

FDA-inspected facilities

2 inspected sites, newest inspection first.

Out Of The Shell, LLC and the FDA: common questions

Has Out Of The Shell, LLC received an FDA warning letter?

No FDA warning letter addressed to the name "Out Of The Shell, LLC" is on file. This answer covers that name only: letters addressed to a related company name or to one of its sites are listed on that name's or site's own page.

Has Out Of The Shell, LLC received an FDA Form 483?

FDA has not published a Form 483 for "Out Of The Shell, LLC" in its reading room. FDA publishes some Form 483s, not all of them.

When did the FDA last inspect Out Of The Shell, LLC?

The most recent FDA inspection on file ended Apr 16, 2026 at South El Monte, CA and was classified NAI. FDA has 2 inspections of Out Of The Shell, LLC on file.