SpecGx LLC [St. Louis / United States of America]

SpecGx LLC [St. Louis / United States of America] located in ST. LOUIS MO, United States of America under the [Mallinckrodt PLC] organization had its last known inspection on 11 Feb 2022. There are 17 known inspections on record.

Site Details

Industries:
Human Drugs, Food and Cosmetics
Tags:
Human Drugs, Analytical Testing, FDF Manufacturer, API Manufacturer, Manufacturer, Food and Cosmetics, Packaging
Parent Organization:
Mallinckrodt PLC
Last Inspection Date:
11 Feb 2022
FEI:
1940521
Redica ID:

SpecGx LLC [St. Louis / United States of America]'s Most Recent Documents

Publish Date Document Type Title
September, 2019 EIR SpecGx LLC - EIR, 2019-09-12
September, 2019 FDA 483 Response SpecGx LLC - Form 483R, 2019-09-27
September, 2019 FDA 483 SpecGx LLC - Form 483, 2019-09-12
November, 2016 EIR SpecGx LLC - EIR, 2016-11-22
November, 2016 FDA 483 SpecGx LLC - Form 483, 2016-11-22

Experience Redica Systems’s NEW site dashboards and profiles

Redica Systems customers can leverage the full Quality and Regulatory Intelligence suite, with powerful analysis covering thousands of sites around the world. You can search by FEI, or more powerfully, by the Redica ID, our universal identifier for global life sciences manufacturing sites, an industry first.

Investigator Profiles are not sold as on-demand documents. If you’d like to see one, fill out the form below to connect with our Sales Team and get it in your inbox as little as 24 hours.

Site Profile Icon

Loading...

Site Profiles Are Just the Tip of the Iceberg

Becoming a Redica Systems customer not only provides you with unlimited access to our extensive inventory of site profiles, but also grants you access to:

Inspection Intelligence

  • Pre-Approval Inspection (PAI) trends
  • The ability to filter nearly any FDA enforcement action by GxP labels like GMP, GCP, etc.
  • Latest 483s: see what the trends are across all FDA Investigators
  • CFR Heatmap: Citations aggregated by Subpart by Year

Vendor Intelligence

  • Full inspection histories for your vendors down to the specific site level
  • All of the functionality mentioned above but isolated to just your vendors

Regulatory Intelligence

  • Zero in on the trends for a specific agency/regulator (ex. FDA, MHRA, EMA, Health Canada)
  • All the latest "Signals" from agencies around the world, segmented by Country, Type (ex. Guidance, Decree...), Category (ex. Rules/Regulations/Guidance, News, Reports...), Theme (ex. Cell and Gene Therapy, AI...), and more