Drug factory · FDA FEI 3009498040
Kreitchman PET Center
722 W 168 St (R-1 Level), New York, NY, United States
Problems found, fixed voluntarily at FDA's last inspection, Dec 15, 2017.
Voluntary Action Indicated: inspectors found problems, but not serious enough for FDA to take action. The company is expected to fix them.
1 drug inspection on record since 2017: 0 with no problems, 1 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Ammonia N-13 | Makes it | Kreitchman PET Center | 62072-456 |
| Fludeoxyglucose F-18 | Makes it | Kreitchman PET Center | 62072-008 |
| Fluoride Ion F-18 | Makes it | Kreitchman PET Center | 62072-500 |
| Fluoroestradiol F-18 | Makes it | GE Healthcare Inc. | 72874-001 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Dec 15, 2017 | Problems found, fixed voluntarily | Drug Quality Assurance | 3 |
What inspectors wrote down
From FDA's Form 483 citations: conditions an investigator observed that may violate drug manufacturing rules, as FDA published them.
Dec 15, 2017 inspection
- Personnel not qualified 21 CFR 212.10
Your personnel lack the training to perform their assigned functions. - Written QA procedures established, followed 21 CFR 212.20(e)
You did not establish and follow written quality assurance procedures. - Analytical methods 21 CFR 212.60(c)
Your laboratory analytical methods are not suitable for their intended use.
Registered with FDA for: positron emission tomography drug production.