FDA Inspection
STATLAB MEDICAL PRODUCTSSTATLAB MEDICAL PRODUCTS – FDA Inspection, Apr 22, 2011
Record Details
This FDA Inspection record concerns STATLAB MEDICAL PRODUCTS, with an inspection on April 22, 2011, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- STATLAB MEDICAL PRODUCTS
- Inspection Date
- April 22, 2011
- Product Type
- Drugs
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ID · 9a27d6ff-5751-4a48-9e6f-c4611df06d00
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 723965
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
17- 21 CFR 211.188Prepared for each batch, include complete information
- 21 CFR 211.94(c)Containers & Closures Clean, Sterilized, Pyrogen-free
- 21 CFR 211.165(b)Microbiological testing
- 21 CFR 211.25(a)Training , Education , Experience overall
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.113(b)Procedures for sterile drug products
- 21 CFR 211.186(a)Written procedures followed
- 21 CFR 211.115(a)Reprocessing procedures not written or followed
- 21 CFR 211.67(c)Cleaning/maintenance records not kept
- 21 CFR 211.125(a)Strict control not exercised over labeling issued
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Other FDA inspections of STATLAB MEDICAL PRODUCTS
2| Date | Classification | Office | Project area |
|---|---|---|---|
| April 20, 2016 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| October 4, 2011 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for STATLAB MEDICAL PRODUCTS
- FDA Inspection 970060 - 2016-04-20
- FDA Inspection 749124 - 2011-10-04
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