BBS Enterprises
Form 483 issued February 4, 2026 · Mishawaka, Indiana
- Inspection
- Feb 2 – Feb 4, 2026
- Investigator
- Suyang Qin
- Observations
- 4
- Pages
- 6
- FEI number
- 3009887475
In short: On February 4, 2026, FDA issued a Form 483 with 4 observations to BBS Enterprises in Mishawaka, Indiana (FEI 3009887475) after an inspection that ran Feb 2 – Feb 4, 2026. The investigator was Suyang Qin.
What FDA observed
Preview: the opening words of each observation- 01ISO 13485:2016 Clause 7.5.6
Processes for production and service provision where the resulting output cannot be, or is not, verified…
- 02ISO 13485:2016 Clause 7.2.1
Requirements related to product do not include requirements necessary for specified or…
- 03ISO 13485:2016 Clause 4.1.2
A risk-based approach to the control of the appropriate processes needed for the quality management system…
- 04ISO 13485:2016 Clause 7.1
One or more processes for risk management in product realization have…
This inspection in context
Suyang Qin
9 documents · 2015–2026
Cites 820.70 (production and process controls) more than any other section. Most of their documents are for sites in Indiana.
The firmBBS Enterprises history
The site's inspection history, in date order.
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Questions about this 483
What did FDA find at BBS Enterprises?
FDA listed 4 observations on this Form 483. The opening words of each observation are shown on this page.
Who inspected BBS Enterprises?
Suyang Qin is named on this Form 483, for the inspection of Feb 2 – Feb 4, 2026. Each investigator has a profile showing what they cite most.
When was BBS Enterprises inspected by FDA?
The inspection ran Feb 2 – Feb 4, 2026, and the Form 483 is dated February 4, 2026.
How do I get the full Form 483 for BBS Enterprises?
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.