Drug factory · FDA FEI 3001452367
Pace Analytical Life Sciences, LLC
1311 Helmo Ave N, Oakdale, MN, United States
Problems found, fixed voluntarily at FDA's last inspection, May 29, 2026.
Voluntary Action Indicated: inspectors found problems, but not serious enough for FDA to take action. The company is expected to fix them.
6 drug inspections on record since 2011: 2 with no problems, 4 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Levoketoconazole | Tests it | Xeris Pharmaceuticals, Inc. | 72065-003 |
| Metformin and Pioglitazone | Tests it | Takeda Pharmaceuticals America, Inc. | 64764-158 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| May 29, 2026 | Problems found, fixed voluntarily | Drug Quality Assurance | 2 |
| Jul 19, 2024 | No problems found | Drug Quality Assurance | — |
| Feb 7, 2018 | Problems found, fixed voluntarily | Drug Quality Assurance | 3 |
| May 4, 2015 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Apr 8, 2013 | Problems found, fixed voluntarily | Drug Quality Assurance | 1 |
| Feb 7, 2011 | No problems found | Drug Quality Assurance | — |
What inspectors wrote down
From FDA's Form 483 citations: conditions an investigator observed that may violate drug manufacturing rules, as FDA published them.
May 29, 2026 inspection
- Complete test data included in records 21 CFR 211.194(a)
Laboratory records do not include complete data derived from all tests, examinations and assay necessary to assure compliance with established specifications and standards. - input/output verification 21 CFR 211.68(b)
Input to and output from related systems of formulas and records or data are not checked for accuracy.
Feb 7, 2018 inspection
- Complete test data included in records 21 CFR 211.194(a)
Laboratory records do not include complete data derived from all tests, examinations and assay necessary to assure compliance with established specifications and standards. - 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. - Calibration/Inspection/Checking not done 21 CFR 211.68(a)
Routine checking of electronic equipment is not performed according to a written program designed to assure proper performance. Electronic records are used, but they do not meet requirements to ensure that they are trustworthy, reliable and generally equivalent to paper records.
Apr 8, 2013 inspection
- 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.
Registered with FDA for: analysis.