FDA Inspection
Retro & R-Med Molding, LLCRetro & R-Med Molding, LLC – FDA Inspection, Jul 22, 2021
Record Details
This FDA Inspection record concerns Retro & R-Med Molding, LLC, with an inspection on July 22, 2021, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Retro & R-Med Molding, LLC
- Inspection Date
- July 22, 2021
- Product Type
- Devices
View Company Profile
ID · 9ef362c6-247d-4eae-bace-23c9dbfc6e80
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1147639
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
9- 21 CFR 820.80(b)Lack of or inadequate receiving acceptance procedures
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.184Lack of or inadequate DHR procedures
- 21 CFR 820.80(d)Lack of or inadequate final acceptance procedures
- 21 CFR 820.22Quality audits - Lack of or inadequate procedures
- 21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
- 21 CFR 820.72(a)Calibration, Inspection, etc. Procedures Lack of or Inadequ
- 21 CFR 820.70(a)Process control procedures, Lack of or inadequate procedures
- 21 CFR 820.20(e)Quality System Procedures
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