J.M. Murray Center, Inc.
Form 483 issued August 17, 2016 · Cortland, New York
- Inspection
- Aug 15 – Aug 17, 2016
- Investigator
- Jose O. Hernandez
- Observations
- 5
- Pages
- 4
- FEI number
- 1319147
In short: On August 17, 2016, FDA issued a Form 483 with 5 observations to J.M. Murray Center, Inc. in Cortland, New York (FEI 1319147) after an inspection that ran Aug 15 – Aug 17, 2016. The investigator was Jose O. Hernandez. Most observations concern materials and facilities & equipment.
At a glance
Observations span 4 systems, led by materials.
What FDA observed
Preview: the opening words of each observation- 01
Written procedures are lacking which describe in sufficient detail the receipt, identification, testing, approval and rejection…
- 02
Procedures for the cleaning and maintenance of equipment are deficient regarding the protection of clean equipment…
- 03
Reserve drug product samples are not representative of each lot or batch of drug product and…
- 04
Drug products do not bear an expiration date determined by appropriate stability data to assure they…
This inspection in context
Jose O. Hernandez
12 documents · 2015–2020
Cites 211.160 (general requirements) 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 211.80(a)
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 5 observations on this Form 483, mostly about materials, facilities & equipment and laboratory controls. The opening words of each observation are shown on this page.
Who inspected J.M. Murray Center, Inc.?
Jose O. Hernandez is named on this Form 483, for the inspection of Aug 15 – Aug 17, 2016. Each investigator has a profile showing what they cite most.
When was J.M. Murray Center, Inc. inspected by FDA?
The inspection ran Aug 15 – Aug 17, 2016, and the Form 483 is dated August 17, 2016.
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.