BBS Enterprises
FDA inspection history in Mishawaka, Indiana, 2026
- 1
- Form 483
Every document, by year
- Form 483
2026: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2026One Form 483, at Mishawaka, Indiana.
Cited most
Across all BBS Enterprises observations on file
- ISO 13485:2016 Clause 4.1.2What is the scope of this subpart?1
- ISO 13485:2016 Clause 7.1Scope1
- ISO 13485:2016 Clause 7.2.11
- ISO 13485:2016 Clause 7.5.61
The complete BBS Enterprises file.
All 1 documents as original PDFs. For supplier audits, diligence and inspection prep.
Sites
Mishawaka, Indiana
One Form 483 · 2026 · 4 observations
Latest: Form 483, Feb 4, 2026 →
Documents
1 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2026-02-04 | 483 Form 483 | Mishawaka, Indiana | 4 | $99 |
Investigators on these documents
FEI number 3009887475 · most recent document Feb 4, 2026
About BBS Enterprises
How many FDA Form 483s has BBS Enterprises received?
FDA Intel has 1 Form 483 on file for BBS Enterprises; the most recent is dated Feb 4, 2026.
When was BBS Enterprises last inspected by FDA?
The most recent FDA inspection document on file for BBS Enterprises is a Form 483 dated Feb 4, 2026, for the site in Mishawaka, Indiana.
What did FDA cite at BBS Enterprises?
The regulations cited most in the observations on file for BBS Enterprises are ISO 13485:2016 Clause 4.1.2 (What is the scope of this subpart?), 1 time; ISO 13485:2016 Clause 7.1 (Scope), 1 time; ISO 13485:2016 Clause 7.2.1, 1 time.