Biomat USA Inc
Form 483 issued January 12, 2026 · Mansfield, Ohio
- Inspection
- Jan 5 – Jan 12, 2026
- Investigator
- Nisha C. Patel
- Observations
- 1
- Pages
- 3
- FEI number
- 3022988848
In short: On January 12, 2026, FDA issued a Form 483 with 1 observation to Biomat USA Inc in Mansfield, Ohio (FEI 3022988848) after an inspection that ran Jan 5 – Jan 12, 2026. The investigator was Nisha C. Patel. Most observations concern biologics CGMP; the most-cited regulation is 21 CFR 606.160 (records).
At a glance
1 of 1 observations on this 483 concern biologics cgmp.
Most cited: 21 CFR 606.160(a)(1) (1×)
What FDA observed
Preview: the opening words of each observation- 01
Records are not concurrently maintained with the performance of each significant step in the processing of…
This inspection in context
Nisha C. Patel
2 documents · 2025–2026
Cites 820.90(a) (nonconforming product) more than any other section. Most of their documents are for sites in Ohio.
The firmBiomat USA Inc history
The site's inspection history, in date order.
Similar 483sOther sites cited under 606.160(a)(1)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Biomat USA Inc?
FDA listed 1 observation on this Form 483, mostly about biologics CGMP. The most-cited regulation is 21 CFR 606.160 (records). The opening words of each observation are shown on this page.
Who inspected Biomat USA Inc?
Nisha C. Patel is named on this Form 483, for the inspection of Jan 5 – Jan 12, 2026. Each investigator has a profile showing what they cite most.
When was Biomat USA Inc inspected by FDA?
The inspection ran Jan 5 – Jan 12, 2026, and the Form 483 is dated January 12, 2026.
How do I get the full Form 483 for Biomat USA 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.