SterRx
Form 483 issued November 4, 2021 · Plattsburgh, New York
- Inspection
- Sep 21 – Nov 4, 2021
- Investigators
- Edmund F. Mrak· Lori M. Newman
- Observations
- 12
- Pages
- 26
- FEI number
- 3010840309
In short: On November 4, 2021, FDA issued a Form 483 with 12 observations to SterRx in Plattsburgh, New York (FEI 3010840309) after an inspection that ran Sep 21 – Nov 4, 2021. The investigators were Edmund F. Mrak and Lori M. Newman. Most observations concern facilities & equipment and quality system; the most-cited regulation is 21 CFR 211.42 (design and construction features).
At a glance
Facilities & equipment and quality system account for 8 of 12 observations.
What FDA observed
Preview: the opening words of each observation- 01
Aseptic processing areas are deficient regarding air supply that is filtered through high-efficiency particulate air…
- 02
Container closure systems do not provide adequate protection against foreseeable external factors in storage and use…
- 03
Aseptic processing areas are deficient regarding the system…
- 04
Equipment used in the manufacture, processing, packing or holding of drug products is not of appropriate…
This inspection in context
Edmund F. Mrak
30 documents · 2010–2026
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(c)(10)(iii)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at SterRx?
FDA listed 12 observations on this Form 483, mostly about facilities & equipment, quality system and production. 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?
Edmund F. Mrak and Lori M. Newman are named on this Form 483, for the inspection of Sep 21 – Nov 4, 2021. Each investigator has a profile showing what they cite most.
When was SterRx inspected by FDA?
The inspection ran Sep 21 – Nov 4, 2021, and the Form 483 is dated November 4, 2021.
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.