Nukemed, Inc dba SpectronRx
Form 483 issued May 12, 2022 · SOUTH BEND, Indiana
- Observations
- 2
- Pages
- 3
- FEI number
- 3005176775
In short: On May 12, 2022, FDA issued a Form 483 with 2 observations to Nukemed, Inc dba SpectronRx in SOUTH BEND, Indiana (FEI 3005176775). Most observations concern facilities & equipment and production; the most-cited regulation is 21 CFR 211.113 (control of microbiological contamination).
At a glance
Facilities & equipment and production account for 2 of 2 observations.
Most cited: 21 CFR 211.113 (2×) · 211.42 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Aseptic processing areas are deficient regarding the system…
- 02
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not…
This inspection in context
Questions about this 483
What did FDA find at Nukemed, Inc dba SpectronRx?
FDA listed 2 observations on this Form 483, mostly about facilities & equipment and production. The most-cited regulation is 21 CFR 211.113 (control of microbiological contamination). The opening words of each observation are shown on this page.
When was Nukemed, Inc dba SpectronRx inspected by FDA?
This Form 483 is dated May 12, 2022.
How do I get the full Form 483 for Nukemed, Inc dba SpectronRx?
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.