FDA Inspection
Shair Laboratories, Inc.Shair Laboratories, Inc. – FDA Inspection, Feb 12, 2010
Record Details
This FDA Inspection record concerns Shair Laboratories, Inc., with an inspection on February 12, 2010, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Shair Laboratories, Inc.
- Inspection Date
- February 12, 2010
- Product Type
- Drugs
View Company Profile
ID · f63f13a7-2372-43ba-8db3-888002b59bc0
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 642144
- FDA center
- Human Drugs
- Project area
- Unapproved and Misbranded Drugs
FDA Citations
15- 21 CFR 211.137(a)Expiration date lacking
- 21 CFR 211.25(a)Training , Education , Experience overall
- 21 CFR 211.110(c)In-process materials characteristics testing
- 21 CFR 211.198(a)Procedures to be written and followed
- 21 CFR 211.170(b)Reserve samples identified, representative, stored
- 21 CFR 211.125(a)Strict control not exercised over labeling issued
- 21 CFR 211.165(a)Testing and release for distribution
- 21 CFR 211.105(b)Distinctive ID or code not recorded in batch record
- 21 CFR 211.150(b)Distribution Recall System
- 21 CFR 211.22(a)Lack of quality control unit
Showing 10 of 15 citations.
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Other FDA inspections of Shair Laboratories, Inc.
4| Date | Classification | Office | Project area |
|---|---|---|---|
| April 27, 2017 | NAI | Center for Food Safety and Applied Nutrition | Colors and Cosmetics Technology |
| April 27, 2017 | NAI | Center for Food Safety and Applied Nutrition | Colors and Cosmetics Technology |
| June 1, 2011 | NAI | Center for Drug Evaluation and Research | Unapproved and Misbranded Drugs |
| March 22, 2011 | VAI | Center for Drug Evaluation and Research | Unapproved and Misbranded Drugs |
Other documents for Shair Laboratories, Inc.
- FDA Inspection 1013212 - 2017-04-27
- FDA Inspection 1012931 - 2017-04-27
- FDA Inspection 737843 - 2011-06-01
- FDA Inspection 711505 - 2011-03-22
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