Biomedics Systems, Inc.
Form 483 issued October 4, 2019 · San Juan, Puerto Rico
- Inspection
- Oct 1 – Oct 4, 2019
- Investigator
- Marian E. Ramirez
- Observations
- 1
- Pages
- 2
- FEI number
- 3014335379
In short: On October 4, 2019, FDA issued a Form 483 with 1 observation to Biomedics Systems, Inc. in San Juan, Puerto Rico (FEI 3014335379) after an inspection that ran Oct 1 – Oct 4, 2019. The investigator was Marian E. Ramirez. Most observations concern laboratory controls; the most-cited regulation is 21 CFR 211.160 (general requirements).
At a glance
1 of 1 observations on this 483 concern laboratory controls.
Most cited: 21 CFR 211.160(b)(1) (1×)
What FDA observed
Preview: the opening words of each observation- 01
Determinations of conformance to appropriate written specifications for acceptance are deficient in that they are not…
This inspection in context
Marian E. Ramirez
20 documents · 2016–2025
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in Puerto Rico.
The firmBiomedics Systems, Inc. history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.160(b)(1)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Biomedics Systems, Inc.?
FDA listed 1 observation on this Form 483, mostly about laboratory controls. The most-cited regulation is 21 CFR 211.160 (general requirements). The opening words of each observation are shown on this page.
Who inspected Biomedics Systems, Inc.?
Marian E. Ramirez is named on this Form 483, for the inspection of Oct 1 – Oct 4, 2019. Each investigator has a profile showing what they cite most.
When was Biomedics Systems, Inc. inspected by FDA?
The inspection ran Oct 1 – Oct 4, 2019, and the Form 483 is dated October 4, 2019.
How do I get the full Form 483 for Biomedics Systems, 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.