FDA Inspection
Carnegie Science Center Henry J. Buhl PlanetariumCarnegie Science Center Henry J. Buhl Planetarium – FDA Inspection, Jul 10, 2018
Record Details
This FDA Inspection record concerns Carnegie Science Center Henry J. Buhl Planetarium, with an inspection on July 10, 2018, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- July 10, 2018
- Product Type
- Devices
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ID · 5fdc2408-4b02-4f89-831a-24efc14a13d9
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1060712
- FDA center
- Medical Devices & Rad Health
- Project area
- Radiation Control and Health Safety Act
- Outcome
- Form 483 issued
FDA Citations
7- 21 CFR 1040.10(g)(3)Class IV "Danger" label
- 21 CFR 1040.11(c)Demonstration laser products
- 21 CFR 1010.4(d)Variances - Improper certification
- 21 CFR 1002.13Failure to submit
- 21 CFR 1002.30(a)(1)Quality control procedures
- 21 CFR 1002.30(a)(2)Methods, devices, procedures for testing
- 21 CFR 1002.31(a)Five year requirement
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Other FDA inspections of Carnegie Science Center Henry J. Buhl Planetarium
1| Date | Classification | Office | Project area |
|---|---|---|---|
| April 28, 2011 | NAI | Center for Devices and Radiological Health | Radiation Control and Health Safety Act |
Other documents for Carnegie Science Center Henry J. Buhl Planetarium
- FDA Inspection 722684 - 2011-04-28
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