FDA Inspection
Poonglim Pharmatech Inc.Poonglim Pharmatech Inc. – FDA Inspection, Jan 16, 2025
Record Details
This FDA Inspection record concerns Poonglim Pharmatech Inc., with an inspection on January 16, 2025, issued by the Office of Inspections and Investigations, covering medical devices & rad health.
- Company
- Poonglim Pharmatech Inc.
- Inspection Date
- January 16, 2025
- Product Type
- Medical Devices & Rad Health
View Company Profile
ID · 140fc1b1-ed57-46b1-abb8-7dc85a14020d
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1260164
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Medical Devices
- Outcome
- Form 483 issued
FDA Citations
5- 21 CFR 820.181DMR - not or inadequately maintained
- 21 CFR 820.30(a)Design control - no procedures
- 21 CFR 820.120Lack of or inadequate procedures for labeling
- 21 CFR 830.300(a)Devices subject to device identification GUDID data submission requirements.
- 21 CFR 803.17Lack of Written MDR Procedures
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