FDA Inspection
Sewaren Innovative Pharmaceutical Packaging dba SIPPSewaren Innovative Pharmaceutical Packaging dba SIPP – FDA Inspection, Jun 28, 2016
Record Details
This FDA Inspection record concerns Sewaren Innovative Pharmaceutical Packaging dba SIPP, with an inspection on June 28, 2016, issued by the Center for Drug Evaluation and Research, covering drugs.
- Inspection Date
- June 28, 2016
- Product Type
- Drugs
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ID · 698c05ea-e5a7-40ba-85a5-10d8b09b92a0
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 982417
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
3- 21 CFR 211.137(a)Expiration date lacking
- 21 CFR 211.113(b)Validation lacking for sterile drug products
- 21 CFR 211.165(a)Testing and release for distribution
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