FDA Inspection
Sirona Hygiene Private LimitedSirona Hygiene Private Limited – FDA Inspection, May 25, 2023
Record Details
This FDA Inspection record concerns Sirona Hygiene Private Limited, with an inspection on May 25, 2023, issued by the Office of Inspections and Investigations.
- Inspection Date
- May 25, 2023
View Company Profile
ID · a4554816-39fb-47f7-88a9-bde3c1596697
Inspection Facts
- Inspection number
- 1206653
- FDA center
- Medical Devices & Rad Health
- Outcome
- Form 483 issued
FDA Citations
4- 21 CFR 803.17Lack of Written MDR Procedures
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
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