Biomat USA, Inc.
Form 483 issued January 9, 2025
- Inspection
- Jan 6 – Jan 9, 2025
- Investigator
- Emily B. Camire
- Observations
- 4
- Pages
- 4
- FEI number
- 3011853315
In short: On January 9, 2025, FDA issued a Form 483 with 4 observations to Biomat USA, Inc. (FEI 3011853315) after an inspection that ran Jan 6 – Jan 9, 2025. The investigator was Emily B. Camire. Most observations concern biologics CGMP; the most-cited regulation is 21 CFR 606.100 (standard operating procedures).
At a glance
3 of 4 observations on this 483 concern biologics cgmp.
Most cited: 21 CFR 606.100 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 0121 CFR 606
Failure of equipment to perform in the manner for which it was designed so as to…
- 02
Failure to perform a thorough investigation of an unexplained discrepancy and a failure of a lot…
- 03
Records are not concurrently maintained with the performance of each significant step in the collection of…
- 04
Written standard operating procedures including all steps to be followed in the collection of blood and…
This inspection in context
Emily B. Camire
4 documents · 2023–2026
Cites 606.100 (standard operating procedures) more than any other section. Most of their documents are for sites in California.
The firmBiomat USA, Inc. history
The site's inspection history, in date order.
Similar 483sOther sites cited under 606.100
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Biomat USA, Inc.?
FDA listed 4 observations on this Form 483, mostly about biologics CGMP. The most-cited regulation is 21 CFR 606.100 (standard operating procedures). The opening words of each observation are shown on this page.
Who inspected Biomat USA, Inc.?
Emily B. Camire is named on this Form 483, for the inspection of Jan 6 – Jan 9, 2025. Each investigator has a profile showing what they cite most.
When was Biomat USA, Inc. inspected by FDA?
The inspection ran Jan 6 – Jan 9, 2025, and the Form 483 is dated January 9, 2025.
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.