Drug factory · FDA FEI 3001237796

The Ritedose Corporation

1 Technology Circle, Columbia, SC, United States

What it does, for whom

FDA inspection history

What inspectors wrote down

From FDA's Form 483 citations: conditions an investigator observed that may violate drug manufacturing rules, as FDA published them.

Feb 28, 2025 inspection

• Validation lacking for sterile drug products 21 CFR 211.113(b)
  Procedures designed to prevent microbiological contamination of drug products purporting to be sterile did not include adequate validation of the aseptic process.
• Validation lacking for sterile drug products 21 CFR 211.113(b)
  Procedures designed to prevent microbiological contamination of drug products purporting to be sterile did not include adequate validation of the aseptic process.
• Investigations of discrepancies, failures 21 CFR 211.192
  There is a failure to thoroughly review any unexplained discrepancy whether or not the batch has been already distributed.
• Investigations of discrepancies, failures 21 CFR 211.192
  There is a failure to thoroughly review any unexplained discrepancy whether or not the batch has been already distributed.
• Defined areas of adequate size for operations 21 CFR 211.42(c)
  The separate or defined areas and control systems necessary to prevent contamination or mix-ups are deficient.
• Defined areas of adequate size for operations 21 CFR 211.42(c)
  The separate or defined areas and control systems necessary to prevent contamination or mix-ups are deficient.

Mar 22, 2022 inspection

• Investigations of discrepancies, failures 21 CFR 211.192
  There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch or any of its components to meet any of its specifications whether or not the batch has been already distributed.
• Investigations of discrepancies, failures 21 CFR 211.192
  There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch or any of its components to meet any of its specifications whether or not the batch has been already distributed.

Mar 3, 2017 inspection

• Following/documenting laboratory controls 21 CFR 211.160(a)
  Established laboratory control mechanisms are not followed.
• Following/documenting laboratory controls 21 CFR 211.160(a)
  Established laboratory control mechanisms are not followed.
• Documentation 21 CFR 820.100(b)
  Corrective and preventive action activities and/or results have not been adequately documented.
• Documentation 21 CFR 820.100(b)
  Corrective and preventive action activities and/or results have not been adequately documented.
• Lack of or inadequate organizational structure 21 CFR 820.20(b)
  The organizational structure has not been adequately established and maintained to ensure that devices are designed and produced in accordance with 21 CFR 820.
• Lack of or inadequate organizational structure 21 CFR 820.20(b)
  The organizational structure has not been adequately established and maintained to ensure that devices are designed and produced in accordance with 21 CFR 820.
• Management review - Lack of or inadequate procedures 21 CFR 820.20(c)
  Procedures for management review have not been adequately established.
• Management review - Lack of or inadequate procedures 21 CFR 820.20(c)
  Procedures for management review have not been adequately established.
• Design history file 21 CFR 820.30(j)
  The design history file was not established.
• Design history file 21 CFR 820.30(j)
  The design history file was not established.

Registered with FDA for: analysis; label; manufacture; pack; repack.