FDA Inspection
Maitland Engineering. Inc.FDA Inspection 1253749 - Maitland Engineering. Inc. - October 31, 2024
Record Details
This FDA Inspection record concerns Maitland Engineering. Inc., with an inspection on October 31, 2024, issued by the Detroit District Office, covering medical devices & rad health.
- Company
- Maitland Engineering. Inc.
- Inspection Date
- October 31, 2024
- Product Type
- Medical Devices & Rad Health
View Company Profile
ID · 807a269c-dc93-46e7-8d73-a8cd58e96ed2
Inspection Facts
- Inspection number
- 1253749
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Medical Devices
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.72(a)Calibration, Inspection, etc. Procedures Lack of or Inadequ
- 21 CFR 820.75(a)Lack of or inadequate process validation
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Other FDA inspections of Maitland Engineering. Inc.
2| Date | Classification | Office | Project area |
|---|---|---|---|
| October 15, 2021 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| September 8, 2017 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Maitland Engineering. Inc.
- FDA Inspection 1155180 - 2021-10-15
- FDA Inspection 1025573 - 2017-09-08
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