FDA Intel

SterRx

Form 483 issued June 28, 2023 · Plattsburgh, New York

Inspection
Jun 1 – Jun 28, 2023
Investigators
Edmund F. Mrak· Pushpa S. Jayasekara
Observations
7
Pages
11
FEI number
3010840309

In short: On June 28, 2023, FDA issued a Form 483 with 7 observations to SterRx in Plattsburgh, New York (FEI 3010840309) after an inspection that ran Jun 1 – Jun 28, 2023. The investigators were Edmund F. Mrak and Pushpa S. Jayasekara. Most observations concern facilities & equipment and materials.

At a glance

Facilities & equipment and materials account for 5 of 7 observations.

Facilities & equipment4
Materials1
Production1
Laboratory controls1

What FDA observed

Preview: the opening words of each observation
  1. 01
    21 CFR 211.80(b)

    There was a failure to handle and store components and closures at all times in a…

  2. 02
    21 CFR 211.28(a)

    Protective apparel is not worn as necessary to protect…

  3. 03
    21 CFR 211.42(c)(10)(iv)

    Aseptic processing areas are deficient regarding the system…

  4. 04
    21 CFR 211.63

    Equipment used in the manufacture, processing, packing or holding of drug products is not of appropriate…

3 more observations

Plus the full detail behind each one, exactly as FDA wrote it.

Get the full 483

This inspection in context

The investigator

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 firm

SterRx history

All 5 documents on file for this site, in date order, with what was cited at each inspection.

Similar 483s

Other sites cited under 211.80(b)

See how FDA wrote the same problem up elsewhere.

Questions about this 483

What did FDA find at SterRx?

FDA listed 7 observations on this Form 483, mostly about facilities & equipment, materials and production. The opening words of each observation are shown on this page.

Who inspected SterRx?

Edmund F. Mrak and Pushpa S. Jayasekara are named on this Form 483, for the inspection of Jun 1 – Jun 28, 2023. Each investigator has a profile showing what they cite most.

When was SterRx inspected by FDA?

The inspection ran Jun 1 – Jun 28, 2023, and the Form 483 is dated June 28, 2023.

How do I get the full Form 483 for SterRx?

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