Gentell

12 FDA enforcement records linked to this company.

• recall — Class II2017-05-31

  GMP Deviations; product may not meet cGMP requirements

• recall — Class II2017-01-11

  CGMP Deviations

• recall — Class II2017-01-11

  CGMP Deviations

• 4832016-12-13

  Control procedures to monitor and validate performance

• 4832016-12-13

  Testing and release for distribution

• 4832016-12-13

  Procedures for non-sterile drug products

• 4832016-12-13

  In-process materials characteristics testing

• 4832016-12-13

  Lack of written stability program

• 4832016-12-13

  Supervisor Training/Education/Experience

• 4832016-12-13

  Scientifically sound laboratory controls

• 4832016-12-13

  Component identity verification

• 4832016-12-13

  Items to cover on annual reviews