FDA Inspection
Carlco Technical Plastics - LatrobeCarlco Technical Plastics - Latrobe – FDA Inspection, May 17, 2018
Record Details
This FDA Inspection record concerns Carlco Technical Plastics - Latrobe, with an inspection on May 17, 2018, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 3a56331b-65cd-4af9-b7be-893a493b3e9f
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1052602
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
5- 21 CFR 820.90(b)(1)Procedures for product review,disposition lack of/inadequate
- 21 CFR 820.72(a)Calibration, Inspection, etc. Procedures Lack of or Inadequ
- 21 CFR 820.75(a)Documentation
- 21 CFR 820.90(a)Nonconforming product control
- 21 CFR 820.250(b)Sampling plans
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Other FDA inspections of Carlco Technical Plastics - Latrobe
2| Date | Classification | Office | Project area |
|---|---|---|---|
| March 26, 2025 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| March 9, 2022 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Carlco Technical Plastics - Latrobe
- FDA Inspection 1265676 - 2025-03-26
- FDA Inspection 1167039 - 2022-03-09
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