Drug factory · FDA FEI 2623531

Pace Analytical, Inc

Industrial Zone El Retiro Calle B And C, San German, PR, United States

Problems found, fixed voluntarily at FDA's last inspection, Aug 7, 2025.

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 2009: 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

Ended	Result	Program	Problems noted
Aug 7, 2025	Problems found, fixed voluntarily	Drug Quality Assurance	2
Nov 9, 2018	Problems found, fixed voluntarily	Drug Quality Assurance	—
Jul 9, 2015	Problems found, fixed voluntarily	Drug Quality Assurance	2
Oct 31, 2012	No problems found	Drug Quality Assurance	—
Sep 6, 2011	No problems found	Drug Quality Assurance	—
Jun 26, 2009	Problems found, fixed voluntarily	Drug Quality Assurance	—

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

Following/documenting laboratory controls 21 CFR 211.160(a)
Established standards and laboratory control mechanisms are not followed and documented at the time of performance.
Drug products-sampling procedures/specifications 21 CFR 211.160(b)(3)
Laboratory controls do not include a determination of conformance to appropriate specifications for drug products.

Lab controls established, including changes 21 CFR 211.160(a)
The establishment of laboratory control mechanisms including any changes thereto, are not reviewed and approved by the quality control unit.
Scientifically sound laboratory controls 21 CFR 211.160(b)
Laboratory controls do not include the establishment of scientifically sound and appropriate test procedures designed to assure that components conform to appropriate standards of identity, strength, quality and purity.

Registered with FDA for: analysis.