J.M. Murray Center, Inc.
Form 483 issued April 30, 2021 · Cortland, New York
- Inspection
- Apr 28 – Apr 30, 2021
- Investigator
- Mindy M. Chou
- Observations
- 4
- Pages
- 3
- FEI number
- 1319147
In short: On April 30, 2021, FDA issued a Form 483 with 4 observations to J.M. Murray Center, Inc. in Cortland, New York (FEI 1319147) after an inspection that ran Apr 28 – Apr 30, 2021. The investigator was Mindy M. Chou. Most observations concern facilities & equipment and production.
At a glance
Facilities & equipment and production account for 3 of 4 observations.
What FDA observed
Preview: the opening words of each observation- 01
Procedures for the cleaning and maintenance of equipment are deficient regarding the protection of clean equipment…
- 02
There are no written procedures for production and process controls designed to assure that the drug…
- 03
The quality control unit lacks authority to review production records to assure that…
- 04
Routine calibration, inspection and checking of automatic, mechanical and electronic equipment is not performed according to…
This inspection in context
Mindy M. Chou
37 documents · 2015–2026
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in New York.
The firmJ.M. Murray Center, Inc. history
All 4 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.67(b)(5)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at J.M. Murray Center, Inc.?
FDA listed 4 observations on this Form 483, mostly about facilities & equipment, production and quality system. The opening words of each observation are shown on this page.
Who inspected J.M. Murray Center, Inc.?
Mindy M. Chou is named on this Form 483, for the inspection of Apr 28 – Apr 30, 2021. Each investigator has a profile showing what they cite most.
When was J.M. Murray Center, Inc. inspected by FDA?
The inspection ran Apr 28 – Apr 30, 2021, and the Form 483 is dated April 30, 2021.
How do I get the full Form 483 for J.M. Murray Center, Inc.?
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.