Drug factory · FDA FEI 2214690
SGS North America Inc.
75 Passaic Ave, Fairfield, NJ, United States
Problems found, fixed voluntarily at FDA's last inspection, Jun 9, 2026.
Voluntary Action Indicated: inspectors found problems, but not serious enough for FDA to take action. The company is expected to fix them.
8 drug inspections on record since 2010: 4 with no problems, 4 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Abametapir | Tests it | Dr. Reddy's Laboratories Inc. | 43598-921 |
| Capsaicin | Tests it | Averitas Pharma, Inc. | 72512-928, 72512-929, 72512-930 |
| Delafloxacin | Tests it | Melinta Therapeutics, LLC | 70842-101, 70842-102 |
| Eflornithine | Tests it | Uswm, LLC | 78670-150 |
| Morphine | Tests it | Nortec Development Associates, Inc. | 42689-005, 42689-006, 42689-007 +3 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Jun 9, 2026 | Problems found, fixed voluntarily | Drug Quality Assurance | 1 |
| Aug 1, 2023 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Aug 30, 2017 | No problems found | Drug Quality Assurance | — |
| Jun 7, 2016 | No problems found | Drug Quality Assurance | — |
| Jan 21, 2014 | Problems found, fixed voluntarily | Drug Quality Assurance | 3 |
| Nov 21, 2011 | No problems found | Drug Quality Assurance | — |
| Apr 7, 2011 | No problems found | Drug Quality Assurance | — |
| Jan 14, 2010 | Problems found, fixed voluntarily | 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.
Jun 9, 2026 inspection
- Scientifically sound laboratory controls 21 CFR 211.160(b)
Laboratory controls do not include the establishment of scientifically sound and appropriate specifications, standards, sampling plans and test procedures designed to assure that components, drug product containers, closures, in-process materials, labeling and drug products conform to appropriate standards of identity, strength, quality and purity.
Jan 21, 2014 inspection
- Following/documenting laboratory controls 21 CFR 211.160(a)
Established laboratory control mechanisms are not documented at the time of performance. - Scientifically sound laboratory controls 21 CFR 211.160(b)
Laboratory controls do not include the establishment of scientifically sound and appropriate standards designed to assure that drug products conform to appropriate standards of identity, strength, quality and purity. - Training , Education , Experience overall 21 CFR 211.25(a)
Employees engaged in the processing of a drug product lack the training required to perform their assigned functions.
Registered with FDA for: analysis.