Nanobots Healthcare, LLC dba Assurance Infusion
Form 483 issued December 3, 2019 · Houston, Texas
- Inspection
- Dec 3, 2019
- Investigator
- Stephen D. Brown
- Observations
- 10
- Pages
- 3
- FEI number
- 3015617746
In short: On December 3, 2019, FDA issued a Form 483 with 10 observations to Nanobots Healthcare, LLC dba Assurance Infusion in Houston, Texas (FEI 3015617746) after an inspection that ran Dec 3, 2019. The investigator was Stephen D. Brown. Most observations concern production and laboratory controls; the most-cited regulation is 21 CFR 211.113 (control of microbiological contamination).
At a glance
Production and laboratory controls account for 7 of 10 observations.
Most cited: 21 CFR 211.113 (5×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Observation 1: scanned text, readable in the full document.
- 02
On 11/19/2019, I noted turbidity and/or precipitate in…
- 03
Observation 3: scanned text, readable in the full document.
- 04
The ISO 5 classified area was not…
This inspection in context
Stephen D. Brown
42 documents · 2006–2021
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in Texas.
The firmNanobots Healthcare, LLC dba Assurance Infusion history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.113
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Nanobots Healthcare, LLC dba Assurance Infusion?
FDA listed 10 observations on this Form 483, mostly about production, laboratory controls and facilities & equipment. The most-cited regulation is 21 CFR 211.113 (control of microbiological contamination). The opening words of each observation are shown on this page.
Who inspected Nanobots Healthcare, LLC dba Assurance Infusion?
Stephen D. Brown is named on this Form 483, for the inspection of Dec 3, 2019. Each investigator has a profile showing what they cite most.
When was Nanobots Healthcare, LLC dba Assurance Infusion inspected by FDA?
The inspection ran Dec 3, 2019, and the Form 483 is dated December 3, 2019.
How do I get the full Form 483 for Nanobots Healthcare, LLC dba Assurance Infusion?
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.