Epic Pharma

17 FDA enforcement records linked to this company.

• 4832023-10-23

  Cleaning SOPs/instructions

• recall — Class II2019-10-16

  Presence of Foreign Tablets/Capsules: Estradiol 1 mg was found in a 100 count bottle of Estradiol 0.5 mg Tablets.

• 4832019-02-01

  Calibration/Inspection/Checking not done

• 4832019-02-01

  In-process conformity - examination, sample testing

• 4832019-02-01

  Cleaning / Sanitizing / Maintenance

• 4832019-02-01

  Procedures To Be in Writing

• 4832019-02-01

  Control procedures to monitor and validate performance

• 4832019-02-01

  Storage under appropriate conditions

• recall — Class II2018-12-26

  Presence of foreign tablet/capsule: A single foreign tablet was found in pharmacy dispensed bottle of 30 Estradiol 2 mg tablets.

• 4832018-11-06

  Failure to develop written procedures

• 4832017-04-21

  Procedure Deviations Recorded and Justified

• 4832017-04-21

  Calibration/Inspection/Checking not done

• 4832015-06-04

  Procedure Deviations Recorded and Justified

• 4832015-06-04

  Scientifically sound laboratory controls

• 4832015-06-04

  Absence of Written Procedures