FDA Inspection
Lee Pharmaceuticals, IncLee Pharmaceuticals, Inc – FDA Inspection, Sep 27, 2010
Record Details
This FDA Inspection record concerns Lee Pharmaceuticals, Inc, with an inspection on September 27, 2010, issued by the Center for Food Safety and Applied Nutrition, covering food/cosmetics.
- Company
- Lee Pharmaceuticals, Inc
- Inspection Date
- September 27, 2010
- Product Type
- Food/cosmetics
View Company Profile
ID · f8631c2c-ee7b-4ea2-8616-d988bb05ae2b
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 682400
- FDA center
- Foods & Cosmetics
- Project area
- Food Composition, Standards, Labeling and Econ
FDA Citations
12- 21 CFR 211.68(b)Computer control of master formula records
- 21 CFR 211.165(b)Microbiological testing
- 21 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
- 21 CFR 211.63Equipment Design, Size and Location
- 21 CFR 211.68(b)Backup file not maintained
- 21 CFR 211.160(b)(4)Calibration - at intervals, written program, remedial action
- 21 CFR 211.22(a)Approve or reject components, products
- 21 CFR 211.100(a)Absence of Written Procedures
- 21 CFR 211.166(a)(2)Stability sample storage conditions described
- 21 CFR 211.166(b)Tentative expiration date
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Other FDA inspections of Lee Pharmaceuticals, Inc
2| Date | Classification | Office | Project area |
|---|---|---|---|
| January 13, 2012 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| June 8, 2010 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for Lee Pharmaceuticals, Inc
- FDA Inspection 766655 - 2012-01-13
- FDA Inspection 667225 - 2010-06-08
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