FDA Inspection
Shair Laboratories, Inc.Shair Laboratories, Inc. – FDA Inspection, Mar 22, 2011
Record Details
This FDA Inspection record concerns Shair Laboratories, Inc., with an inspection on March 22, 2011, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Shair Laboratories, Inc.
- Inspection Date
- March 22, 2011
- Product Type
- Drugs
View Company Profile
ID · c53e2976-581f-47b2-a29c-fb6729532dec
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 711505
- FDA center
- Human Drugs
- Project area
- Unapproved and Misbranded Drugs
FDA Citations
27- 21 CFR 211.103Actual vs. theoretical yields not determined
- 21 CFR 211.188Prepared for each batch, include complete information
- 21 CFR 211.142(a)Quarantine - actual practice
- 21 CFR 211.137(a)Expiration date lacking
- 21 CFR 211.25(a)Training--operations, GMPs, written procedures
- 21 CFR 211.110(c)In-process materials characteristics testing
- 21 CFR 211.122(b)Labeling and packaging improperly approved/released
- 21 CFR 211.198(a)Complaint Handling Procedure
- 21 CFR 211.34Consultant Records
- 21 CFR 211.170(b)(1)Retention time of reserve samples, in general
Showing 10 of 27 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 |
| February 12, 2010 | OAI | 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 642144 - 2010-02-12
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