Drug factory · FDA FEI 1000139876
Spectral Data Services, Inc.
818 Pioneer Street, Champaign, IL, United States
Problems found, fixed voluntarily at FDA's last inspection, Jul 28, 2025.
Voluntary Action Indicated: inspectors found problems, but not serious enough for FDA to take action. The company is expected to fix them.
5 drug inspections on record since 2009: 4 with no problems, 1 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Risperidone | Tests it | Indivior Inc. | 12496-0090, 12496-0120 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Jul 28, 2025 | Problems found, fixed voluntarily | Drug Quality Assurance | 4 |
| May 31, 2016 | No problems found | Drug Quality Assurance | — |
| Apr 15, 2013 | No problems found | Drug Quality Assurance | — |
| Nov 3, 2010 | No problems found | Drug Quality Assurance | — |
| Feb 3, 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.
Jul 28, 2025 inspection
- Written record of investigation incomplete 21 CFR 211.192
Written records of investigations into unexplained discrepancies do not always include the conclusions and follow-up. - 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. - 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. - Computer control of master formula records 21 CFR 211.68(b)
Appropriate controls are not exercised over computers or related systems to assure that changes in master production and control records or other records are instituted only by authorized personnel.
Registered with FDA for: analysis.