FDA Inspection
SCHOTT Pharma AG & Co. KGaASCHOTT Pharma AG & Co. KGaA – FDA Inspection, Aug 14, 2019
Record Details
This FDA Inspection record concerns SCHOTT Pharma AG & Co. KGaA, with an inspection on August 14, 2019, issued by the Office of Inspections and Investigations, covering medical devices & rad health.
- Company
- SCHOTT Pharma AG & Co. KGaA
- Inspection Date
- August 14, 2019
- Product Type
- Medical Devices & Rad Health
View Company Profile
ID · 8540f232-31da-40b7-bd03-085deae9e0e6
Inspection Facts
- Inspection number
- 1099855
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
5- 21 CFR 820.100(b)Documentation
- 21 CFR 820.184DHR - not or inadequately maintained
- 21 CFR 820.198(a)Complaints
- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.80(e)Documentation
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