FDA Inspection
EXACT MEDICAL MANUFACTURING, INC.EXACT MEDICAL MANUFACTURING, INC. – FDA Inspection, May 2, 2019
Record Details
This FDA Inspection record concerns EXACT MEDICAL MANUFACTURING, INC., with an inspection on May 2, 2019, issued by the Center for Devices and Radiological Health, covering devices.
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ID · e6751aff-02a8-4cf8-bcf2-aa7678a16e74
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1089637
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
5- 21 CFR 820.40(b)Document change records, maintained.
- 21 CFR 820.72(a)Calibration, Inspection, etc. Procedures Lack of or Inadequ
- 21 CFR 820.75(a)Documentation
- 21 CFR 820.75(b)Lack/Inad procedure-Monitoring/Control of Validated Proces
- 21 CFR 820.90(b)(2)Product rework documentation, DHR {see also 820.184}
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