FDA Inspection
HLPR, Inc. dba Lakewood ProductsHLPR, Inc. dba Lakewood Products – FDA Inspection, Dec 5, 2017
Record Details
This FDA Inspection record concerns HLPR, Inc. dba Lakewood Products, with an inspection on December 5, 2017, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 03e149c6-d543-45bf-b596-5d12f68bbee8
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1034598
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.184Lack of or inadequate DHR procedures
- 21 CFR 820.72(a)Calibration, Inspection, etc. Procedures Lack of or Inadequ
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