Sciegen Pharmaceuticals Inc

13 FDA enforcement records linked to this company.

• 4832026-05-15

  SOPs not followed / documented

• 4832026-05-15

  Sanitation--buildings not clean, free of infestation

• recall — Class III2023-03-08

  Presence of Foreign Tablets/Capsules: Pharmacist reported presence of some Gabapentin tablets 800 mg comingled in Gabapentin 600 mg 500 count bottles.

• 4832019-06-21

  Investigations of discrepancies, failures

• 4832019-06-21

  Complete instructions, procedures, specifications et. al.

• 4832019-06-21

  Absence of Written Procedures

• recall — Class II2018-11-28

  CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodimethylamine (NDEA) in product.

• recall — Class II2018-11-28

  CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodimethylamine (NDEA) in product.

• recall — Class II2018-11-28

  CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodimethylamine (NDEA) in product.

• recall — Class II2018-11-28

  CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodimethylamine (NDEA) in product.

• recall — Class II2018-11-28

  CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodimethylamine (NDEA) in product.

• recall — Class II2018-11-28

  CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodimethylamine (NDEA) in product.

• 4832015-01-09

  Procedures not in writing, fully followed