Drug factory · FDA FEI 1418028
SGS North America Inc.
616 Heathrow Dr, Lincolnshire, IL, United States
Problems found, fixed voluntarily at FDA's last inspection, Mar 20, 2026.
Voluntary Action Indicated: inspectors found problems, but not serious enough for FDA to take action. The company is expected to fix them.
9 drug inspections on record since 2009: 7 with no problems, 2 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Amifampridine | Tests it | Catalyst Pharmaceuticals, Inc. | 69616-211 |
| Aprepitant | Tests it | Heron Therapeutics, Inc. | 47426-201 |
| Buprenorphine | Tests it | Indivior Inc. | 12496-0100, 12496-0300 |
| Buprenorphine and Naloxone | Tests it | Indivior Inc. | 12496-1202, 12496-1204, 12496-1208 +1 |
| Desmopressin | Tests it | Eton Pharmaceuticals, Inc. | 71863-123 |
| Hydrocortisone | Tests it | Eton Pharmaceuticals, Inc. | 71863-116 |
| Levoketoconazole | Tests it | Xeris Pharmaceuticals, Inc. | 72065-003 |
| Mebrofenin | Tests it | Bracco Diagnostics Inc. | 0270-0083 |
| Risperidone | Tests it | Indivior Inc. | 12496-0090, 12496-0120 |
| Thiosulfate Ion | Tests it | Fennec Pharmaceuticals Inc. | 73077-010 |
| Zinc Cation | Tests it | Eton Pharmaceuticals, Inc. | 71863-124, 71863-125 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Mar 20, 2026 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Jan 10, 2023 | Problems found, fixed voluntarily | Drug Quality Assurance | 1 |
| Apr 24, 2019 | No problems found | Drug Quality Assurance | — |
| Feb 14, 2017 | No problems found | Drug Quality Assurance | — |
| Nov 21, 2014 | No problems found | Drug Quality Assurance | — |
| Dec 3, 2012 | No problems found | Drug Quality Assurance | — |
| Nov 30, 2010 | No problems found | Drug Quality Assurance | — |
| May 27, 2010 | No problems found | Drug Quality Assurance | — |
| Aug 14, 2009 | 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.
Jan 10, 2023 inspection
- Investigations of discrepancies, failures 21 CFR 211.192
There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch or any of its components to meet any of its specifications whether or not the batch has been already distributed.
Registered with FDA for: analysis.