Drug factory · FDA FEI 3008961887
Kettering Medical Center
3535 Southern Blvd., Kettering, OH, United States
Problems found, fixed voluntarily at FDA's last inspection, May 9, 2025.
Voluntary Action Indicated: inspectors found problems, but not serious enough for FDA to take action. The company is expected to fix them.
3 drug inspections on record since 2013: 0 with no problems, 3 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Fludeoxyglucose F-18 | Makes it | Kettering Medical Center | 29998-001 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| May 9, 2025 | Problems found, fixed voluntarily | Drug Quality Assurance | 3 |
| Jun 30, 2015 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Nov 13, 2013 | 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.
May 9, 2025 inspection
- Oversight of production operations 21 CFR 212.20(a)
You did not oversee production operations in a manner to ensure that each PET drug meets the requirements of the FD&C Act as to safety, has the identity and strength that it is supposed to have and meets the quality and purity characteristics that it is supposed to have. - Unique record for each batch 21 CFR 212.50(c)
Each time a batch of a PET drug is produced, your firm does not create a unique batch production and control record. - Documentation of Non-Conforming Product Investigation 21 CFR 212.71(b)
You did not document the results of the investigation and what happened to the rejected PET drug product for a PET drug product that did not meet specifications.
Registered with FDA for: positron emission tomography drug production.