FDA Inspection
Steriscience SP. Z O.O.Steriscience SP. Z O.O. – FDA Inspection, Feb 14, 2014
Record Details
This FDA Inspection record concerns Steriscience SP. Z O.O., with an inspection on February 14, 2014, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Steriscience SP. Z O.O.
- Inspection Date
- February 14, 2014
- Product Type
- Drugs
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ID · 4b6dc44a-8e28-4f8d-a132-aed632ef1913
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 866277
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
12- 21 CFR 211.68(b)Computer control of master formula records
- 21 CFR 211.42(c)(10)(v)Cleaning System
- 21 CFR 211.42(c)(10)(iv)Environmental Monitoring System
- 21 CFR 211.100(a)Changes to Procedures Not Reviewed, Approved
- 21 CFR 211.63Equipment Design, Size and Location
- 21 CFR 211.192Extent of discrepancy, failure investigations
- 21 CFR 211.198(a)Complaint Handling Procedure
- 21 CFR 211.113(b)Procedures for sterile drug products
- 21 CFR 211.186(a)Written procedures followed
- 21 CFR 211.100(a)Absence of Written Procedures
Showing 10 of 12 citations.
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Other FDA inspections of Steriscience SP. Z O.O.
2| Date | Classification | Office | Project area |
|---|---|---|---|
| April 28, 2023 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| September 13, 2012 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Steriscience SP. Z O.O.
- FDA Inspection 1203774 - 2023-04-28
- FDA Inspection 800716 - 2012-09-13
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