FDA & CE Compliance

Strict Adherence to Regulatory and Safety Compliance Guidelines

From Class 1 Lasers to following Current Good Manufacturing Practice (CGMP) regulations, Ackley strictly adheres to FDA and CE compliance guidelines which are essential to the health and safety of workers and consumers.

Below is a general list of our FDA & CE machine compliance information. For complete and specific compliance information regarding a machine – please contact us for details.

Safety and Regulatory Compliance

cGMP Compliance

  • FDA 21 CFR Parts 210 and 211 – Current Good Manufacturing Practice for Pharmaceuticals
  • FDA 21 CFR Part 117 – Current Good Manufacturing Practice for Human Food
  • EU GMP (EudraLex Volume 4)

Data Integrity and Computerized Systems

  • FDA 21 CFR Part 11 – Electronic Records and Electronic Signatures

Laser Safety

  • FDA 21 CFR 1040.10 – Performance Standards for Laser Products (Class I)
  • IEC / EN 60825-1 – Safety of Laser Products

European CE Compliance

  • Machinery Directive 2006/42/EC
  • Low Voltage Directive 2014/35/EU
  • Electromagnetic Compatibility Directive 2014/30/EU

Safety and Electrical Standards

  • ISO 13849-1 – Safety-Related Parts of Control Systems
  • EN ISO 12100 – Risk Assessment and Risk Reduction
  • IEC / EN 60204-1 – Electrical Equipment of Machines
  • NFPA 79 – Electrical Standard for Industrial Machinery

Canadian Food and Drug

  • Canadian Food and Drug Regulations (C.R.C., c. 870), Section C.02.005 – Equipment (GMP)

link to Ackley Hartnett
Back to Top