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Sterling Pharma Solutions — Cramlington

Cramlington, United Kingdom · CDMO

This is a record of what regulators published, not a rating.

Site facts

Company
Sterling Pharma Solutions
Name(s) in FDA data
Sterling Pharma Solutions Ltd.
FEI number(s)
3002806719 (present in FDA Data Dashboard records for this name and city)
Location (as in FDA data)
Cramlington, United Kingdom
Records matched
6 FDA inspections
Most recent FDA inspection in dataset
11 Jul 2025 — VAI

Capabilities (from the company's website)

  • Small molecule
    …80°C High vacuum WFE / SPE unit and high temperature fractionating unit Manufacturing Our small molecule API manufacturing facilities offer: Broad range of intermediate and API trains 1,200 – 13…
  • API / drug substance (chemical)
    …Cramlington, UK API development and manufacturing facilities that can support your product from grammes to to…
  • Highly potent (HPAPI)
    …o lab facilities at 10, 20, 25 and 50L for clinical and commercial API batches up to ~5kg High potency capability at 10 and 20L 10 and 20L small scale cGMP hydrogenation equipment Full range o…
  • Spray drying & particle engineering
    …catalysis Cryogenics Hydroxylamine Organometallic Friedel craft Carbonylation Milling and micronisation Hydrogenation Biological waste treatment Research and Development Centre Our dedicat…
  • Analytical testing
    …nical areas to support a variety of project challenges. Some of our key services include: Analytical chemistry Solid state chemistry Flow chemistry Controlled substances Biocatalysis Cryogenics Hydrox…
  • Solid-state & particle characterization
    …t a variety of project challenges. Some of our key services include: Analytical chemistry Solid state chemistry Flow chemistry Controlled substances Biocatalysis Cryogenics Hydroxylamine Orga…
  • Formulation & process development
    …ntensification World class hazard evaluation laboratory Expertise in technology transfer, process development and industrialisation Solid state chemistry team to support solid form development Pilot…
  • Controlled substances
    …lished in 1969 42 acre facility 490+ employees 90+ molecules Approved for Schedule 1 to 3 controlled substances Contact our Cramlington team Speak to an expert Services Our Cramlington facility delive…

Taken from the company's web page for this site. Source: https://www.sterlingpharmasolutions.com/facilities/cramlington-uk/, checked 16 Oct 2026. Quoted text shows the wording each tag is based on.

Regulatory timeline

Newest first. Each entry links to the published source. Inspection classifications: NAI = no action indicated, VAI = voluntary action indicated, OAI = official action indicated (FDA definitions). Posted 483 citations are FDA's short summaries, not the full Form 483.

  1. 11 Jul 2025
    FDA inspection FDA inspection classified VAI

    Voluntary Action Indicated (VAI). Product type(s): Drugs. Project area(s): Drug Quality Assurance.

    Source: FDA Data Dashboard – Inspections (FEI 3002806719, inspection ID 1311034)

  2. 16 Jun 2021
    FDA inspection FDA inspection classified VAI

    Voluntary Action Indicated (VAI). Product type(s): Drugs. Project area(s): Drug Quality Assurance.

    Source: FDA Data Dashboard – Inspections (FEI 3002806719, inspection ID 1150620)

  3. 09 Feb 2018
    FDA inspection FDA inspection classified NAI

    No Action Indicated (NAI). Product type(s): Veterinary. Project area(s): Monitoring of Marketed Animal Drugs, Feed, and Devices.

    Source: FDA Data Dashboard – Inspections (FEI 3002806719, inspection ID 1048707)

  4. 23 Jun 2017
    FDA inspection FDA inspection classified VAI

    Voluntary Action Indicated (VAI). Product type(s): Drugs. Project area(s): Drug Quality Assurance.

    Source: FDA Data Dashboard – Inspections (FEI 3002806719, inspection ID 1072742)

  5. 07 Nov 2014
    FDA inspection FDA inspection classified NAI

    No Action Indicated (NAI). Product type(s): Drugs. Project area(s): Drug Quality Assurance.

    Source: FDA Data Dashboard – Inspections (FEI 3002806719, inspection ID 904717)

  6. 12 May 2011
    FDA inspection FDA inspection classified NAI

    No Action Indicated (NAI). Product type(s): Drugs. Project area(s): Drug Quality Assurance.

    Source: FDA Data Dashboard – Inspections (FEI 3002806719, inspection ID 729694)

This is a record of what regulators published, not a rating. Absence of a record here does not mean no record exists; see methodology for what we check and how records are matched.