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Surmasis Reprimanded for Lab Records, Equipment Inspections

  • Post author:Sam
  • Post published:July 2, 2018
  • Post category:Drug GMP Report

The FDA hit Surmasis Pharmaceutical of Des Moines, Iowa with a Form 483 after a February inspection revealed problems with laboratory records, computer systems and equipment inspections. Source: Drug GMP…

Continue ReadingSurmasis Reprimanded for Lab Records, Equipment Inspections

Warning Letter Roundup: FDA Warns Five Firms for Quality Deficiencies

  • Post author:Sam
  • Post published:July 2, 2018
  • Post category:Drug GMP Report

The FDA issued warnings to the following facilities in Australia, Korea, the European Union and the United States for deficiencies in records, documentation, GMPs, testing and validation: Source: Drug GMP…

Continue ReadingWarning Letter Roundup: FDA Warns Five Firms for Quality Deficiencies
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