FDA Inspection
Linde Eckstein Gmbh + Co KGLinde Eckstein Gmbh + Co KG – FDA Inspection, Jun 30, 2017
Record Details
This FDA Inspection record concerns Linde Eckstein Gmbh + Co KG, with an inspection on June 30, 2017, issued by the Center for Drug Evaluation and Research, covering drugs.
- Person
- Jamie L. Dion (Issuing Officer)
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ID · 584c2a06-1ee7-47da-bdb6-7c5026335902
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1016800
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
11- 21 CFR 211.103Actual vs. theoretical yields not determined
- 21 CFR 211.188Prepared for each batch, include complete information
- 21 CFR 211.110(a)Control procedures to monitor and validate performance
- 21 CFR 211.101(d)Component addition checked by 2nd person
- 21 CFR 211.194(a)(4)Complete Test Data
- 21 CFR 211.180(e)Records reviewed annually
- 21 CFR 211.165(a)Testing and release for distribution
- 21 CFR 211.84(d)(1)Identity Testing of Each Component
- 21 CFR 211.192Investigations of discrepancies, failures
- 21 CFR 211.166(a)Lack of written stability program
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