Drug factory · FDA FEI 1918751

University of Iowa Pharmaceuticals

115 S Grand Ave Suite G20 Phar, Iowa City, IA, United States

Problems found, fixed voluntarily at FDA's last inspection, Jun 22, 2023.

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: 6 with no problems, 6 with problems fixed voluntarily, 0 with FDA action.

What it does, for whom

Drug	Role	For	NDC
Benzoic Acid and Phenylacetic Acid	Makes it and packages it	Zydus Pharmaceuticals (USA) Inc.	68382-396

Ended	Result	Program	Problems noted
Jun 22, 2023	Problems found, fixed voluntarily	Drug Quality Assurance	—
May 4, 2018	Problems found, fixed voluntarily	Drug Quality Assurance	4
Nov 10, 2015	No problems found	Drug Quality Assurance	—
Nov 6, 2015	No problems found	Drug Quality Assurance	—
Dec 13, 2013	No problems found	Drug Quality Assurance	—
Dec 13, 2013	Problems found, fixed voluntarily	Drug Quality Assurance	4
Nov 11, 2011	Problems found, fixed voluntarily	Drug Quality Assurance	—
Nov 9, 2011	No problems found	Drug Quality Assurance	—
Aug 27, 2009	Problems found, fixed voluntarily	Drug Quality Assurance	—
Aug 21, 2009	No problems found	Drug Quality Assurance	—
Apr 21, 2009	Problems found, fixed voluntarily	Drug Quality Assurance	—
Apr 3, 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.

Test methods 21 CFR 211.165(e)
The accuracy, sensitivity, specificity and reproducibility of test methods have not been established.
Adverse Drug Experience 21 CFR 211.198(a)
Complaint procedures are deficient in that they do not include provisions that allow for the review to determine if the complaints represent unexpected adverse drug experiences which are required to be reported to FDA.
Aseptic Processing Area 21 CFR 211.42(c)(10)
Separate or defined areas to prevent contamination or mix-ups are deficient regarding operations related to aseptic processing of drug products.
Retest of approved components/containers/closures 21 CFR 211.87
Approved components are not retested or reexamined as appropriate for identity, strength, quality and purity after storage for long periods with subsequent approval or rejection by the quality control unit.

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 and documented at the time of performance.
Extent of discrepancy, failure investigations 21 CFR 211.192
Investigations of an unexplained discrepancy and a failure of a batch or any of its components to meet any of its specifications did not extend to other batches of the same drug product and other drug products that may have been associated with the specific failure or discrepancy.
Written record of investigation incomplete 21 CFR 211.192
Written records of investigations into unexplained discrepancies and the failure of a batch or any of its components to meet specifications do not always include the conclusions and follow-up.
Training , Education , Experience overall 21 CFR 211.25(a)
Employees engaged in the manufacture, processing, packing, and holding of a drug product lack the training and experience required to perform their assigned functions.

Registered with FDA for: analysis; label; manufacture; pack; particle size reduction; relabel; repack; sterilize.