Drug factory · FDA FEI 1000115571

Simtra US LLC

927 South Curry Pike, Bloomington, IN, United States

Problems found, fixed voluntarily at FDA's last inspection, Sep 24, 2024.

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

12 drug inspections on record since 2009: 4 with no problems, 8 with problems fixed voluntarily, 0 with FDA action.

What it does, for whom

Drug	Role	For	NDC
Adenosine	Makes it, tests it, packages it, labels it and sterilizes it	Hikma Pharmaceuticals USA Inc.	0641-6113
Aflibercept	Makes it, tests it, packages it and labels it	Regeneron Pharmaceuticals, Inc.	61755-005
Daratumumab	Makes it, packages it and labels it	Janssen Biotech, Inc.	57894-502
Garetosmab	Makes it and tests it	Regeneron Pharmaceuticals, Inc.	61755-012
Golimumab	Makes it and tests it	Janssen Biotech, Inc.	57894-070, 57894-071, 57894-350
Regadenoson	Makes it, tests it, packages it, labels it and sterilizes it	Baxter Healthcare Corporation	36000-364
Ustekinumab	Makes it	Janssen Biotech, Inc.	57894-060, 57894-061, 57894-440 +1

Ended	Result	Program	Problems noted
Sep 24, 2024	Problems found, fixed voluntarily	Drug Quality Assurance	—
Feb 17, 2023	No problems found	Drug Quality Assurance	—
Jul 17, 2017	Problems found, fixed voluntarily	Drug Quality Assurance	1
Oct 24, 2014	Problems found, fixed voluntarily	Drug Quality Assurance	—
May 2, 2014	No problems found	Drug Quality Assurance	—
May 10, 2013	Problems found, fixed voluntarily	Drug Quality Assurance	4
Mar 12, 2013	Problems found, fixed voluntarily	Drug Quality Assurance	2
Sep 27, 2012	Problems found, fixed voluntarily	Drug Quality Assurance	—
Aug 16, 2011	No problems found	Drug Quality Assurance	—
Mar 25, 2011	Problems found, fixed voluntarily	Drug Quality Assurance	2
Sep 23, 2010	Problems found, fixed voluntarily	Drug Quality Assurance	—
Oct 30, 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 do not include adequate validation of the sterilization process.

SOPs not followed / documented 21 CFR 211.100(b)
Written production and process control procedures are not followed in the execution of production and process control functions.
Procedures not in writing, fully followed 21 CFR 211.22(d)
The responsibilities and procedures applicable to the quality control unit are not fully followed.
Procedures To Be in Writing 21 CFR 211.80(a)
Written procedures are lacking which describe in sufficient detail the testing of drug product containers and closures.
Certificates of Testing (Containers, Closures) 21 CFR 211.84(d)(3)
Certificates of testing of containers and closures are accepted in lieu of testing without establishing the reliability of the supplier's test results through appropriate validation of the test results at appropriate intervals.

Procedures for sterile drug products 21 CFR 211.113(b)
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not established.
Extent of discrepancy, failure investigations 21 CFR 211.192
Investigations of an unexplained discrepancy did not extend to other drug products that may have been associated with the specific failure or discrepancy.

Extent of discrepancy, failure investigations 21 CFR 211.192
Investigations of an unexplained discrepancy did not extend to other drug products that may have been associated with the specific failure or discrepancy.
Procedures not in writing, fully followed 21 CFR 211.22(d)
The responsibilities and procedures applicable to the quality control unit are not in writing and fully followed.

Registered with FDA for: analysis; label; manufacture; pack; relabel; sterilize.