SterRx
Form 483 issued March 17, 2017 · Plattsburgh, New York
- Inspection
- Feb 27, 2017
- Investigators
- Chad N. Thompson· Rachael Moliver
- Observations
- 5
- Pages
- 4
- FEI number
- 3010840309
In short: On March 17, 2017, FDA issued a Form 483 with 5 observations to SterRx in Plattsburgh, New York (FEI 3010840309) after an inspection that ran Feb 27, 2017. The investigators were Chad N. Thompson and Rachael Moliver. Most observations concern facilities & equipment and production; the most-cited regulation is 21 CFR 211.42 (design and construction features).
At a glance
Facilities & equipment and production account for 3 of 5 observations.
Most cited: 21 CFR 211.42 (2×)
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 do not include…
- 03
Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the equipment…
- 04
Results of stability testing are not used…
This inspection in context
Chad N. Thompson
7 documents · 2013–2020
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in New York.
The firmSterRx history
All 5 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.42
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at SterRx?
FDA listed 5 observations on this Form 483, mostly about facilities & equipment, production and laboratory controls. The most-cited regulation is 21 CFR 211.42 (design and construction features). The opening words of each observation are shown on this page.
Who inspected SterRx?
Chad N. Thompson and Rachael Moliver are named on this Form 483, for the inspection of Feb 27, 2017. Each investigator has a profile showing what they cite most.
When was SterRx inspected by FDA?
The inspection ran Feb 27, 2017, and the Form 483 is dated March 17, 2017.
How do I get the full Form 483 for SterRx?
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.