FDA Inspection
M W Laboratories IncM W Laboratories Inc – FDA Inspection, Dec 11, 2008
Record Details
This FDA Inspection record concerns M W Laboratories Inc, with an inspection on December 11, 2008, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- M W Laboratories Inc
- Inspection Date
- December 11, 2008
- Product Type
- Drugs
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ID · c021b65f-3848-4853-8668-5831dc5fc854
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 552982
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
12- 21 CFR 211.188Prepared for each batch, include complete information
- 21 CFR 211.165(b)Microbiological testing
- 21 CFR 211.125(f)Procedures Written and Followed
- 21 CFR 211.142Written warehousing procedures established/followed
- 21 CFR 211.113(a)Procedures for non-sterile drug products
- 21 CFR 211.170(b)(1)Retention time of reserve samples, in general
- 21 CFR 211.165(a)Testing and release for distribution
- 21 CFR 211.100(a)Absence of Written Procedures
- 21 CFR 211.22(a)Lack of quality control unit
- 21 CFR 211.166(a)Lack of written stability program
Showing 10 of 12 citations.
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Other FDA inspections of M W Laboratories Inc
2| Date | Classification | Office | Project area |
|---|---|---|---|
| September 15, 2011 | NAI | Center for Food Safety and Applied Nutrition | Colors and Cosmetics Technology |
| November 4, 2008 | VAI | Center for Food Safety and Applied Nutrition | Colors and Cosmetics Technology |
Other documents for M W Laboratories Inc
- FDA Inspection 749276 - 2011-09-15
- FDA Inspection 546244 - 2008-11-04
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