Drug factory · FDA FEI 3001237796

The Ritedose Corporation

1135 Performance Parkway, Columbia, SC, United States

Problems found, fixed voluntarily at FDA's last inspection, Feb 28, 2025.

Voluntary Action Indicated: inspectors found problems, but not serious enough for FDA to take action. The company is expected to fix them.

24 drug inspections on record since 2009: 7 with no problems, 5 with problems fixed voluntarily, 0 with FDA action.

What it does, for whom

Drug	Role	For	NDC
Ensifentrine	Packages it and labels it	Merck Sharp & Dohme LLC	83034-003

Ended	Result	Program	Problems noted
Feb 28, 2025	Problems found, fixed voluntarily	Drug Quality Assurance	6
Feb 28, 2025	Problems found, fixed voluntarily	Drug Quality Assurance	6
Mar 22, 2022	Problems found, fixed voluntarily	Drug Quality Assurance	2
Mar 22, 2022	Problems found, fixed voluntarily	Drug Quality Assurance	2
Apr 18, 2019	No problems found	Bioresearch Monitoring	—
Apr 18, 2019	No problems found	Bioresearch Monitoring	—
Mar 3, 2017	Problems found, fixed voluntarily	Drug Quality Assurance	10
Mar 3, 2017	Problems found, fixed voluntarily	Drug Quality Assurance	10
Jul 31, 2015	Problems found, fixed voluntarily	Drug Quality Assurance	—
Jul 31, 2015	Problems found, fixed voluntarily	Drug Quality Assurance	—
Apr 17, 2014	No problems found	Drug Quality Assurance	—
Apr 17, 2014	No problems found	Drug Quality Assurance	—
Nov 8, 2012	No problems found	Drug Quality Assurance	—
Nov 8, 2012	No problems found	Drug Quality Assurance	—
Sep 9, 2011	No problems found	Drug Quality Assurance	—
Sep 9, 2011	No problems found	Drug Quality Assurance	—
Jan 6, 2011	Problems found, fixed voluntarily	Drug Quality Assurance	—
Jan 6, 2011	Problems found, fixed voluntarily	Drug Quality Assurance	—
Sep 30, 2010	No problems found	Bioresearch Monitoring	—
Sep 30, 2010	No problems found	Bioresearch Monitoring	—
Aug 12, 2010	No problems found	Drug Quality Assurance	—
Aug 12, 2010	No problems found	Drug Quality Assurance	—
Sep 18, 2009	No problems found	Drug Quality Assurance	—
Sep 18, 2009	No problems found	Drug Quality Assurance	—

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

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.

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.

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: label; pack; repack.