FDA Inspection
Tower Laboratories, Ltd.Tower Laboratories, Ltd. – FDA Inspection, Jun 18, 2013
Record Details
This FDA Inspection record concerns Tower Laboratories, Ltd., with an inspection on June 18, 2013, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Tower Laboratories, Ltd.
- Inspection Date
- June 18, 2013
- Product Type
- Drugs
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ID · c1323168-20fb-4f35-83ce-79e42616d648
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 834739
- FDA center
- Human Drugs
- Project area
- Unapproved and Misbranded Drugs
FDA Citations
9- 21 CFR 211.113(a)Procedures for non-sterile drug products
- 21 CFR 211.115(a)Reprocessing procedures not written or followed
- 21 CFR 211.160(a)Lab controls established, including changes
- 21 CFR 211.110(a)(3)Mixing adequacy
- 21 CFR 211.22(a)Approve or reject components, products
- 21 CFR 211.100(a)Absence of Written Procedures
- 21 CFR 211.165(e)Test methods
- 21 CFR 111.320(b)Examination, testing; scientifically valid
- 21 CFR 111.77(a)Specifications not met - reject, quality control
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Other FDA inspections of Tower Laboratories, Ltd.
7| Date | Classification | Office | Project area |
|---|---|---|---|
| July 30, 2025 | VAI | New England District Office | Drug Quality Assurance |
| April 11, 2022 | NAI | Center for Food Safety and Applied Nutrition | Foodborne Biological Hazards |
| March 23, 2018 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| September 1, 2016 | NAI | Center for Food Safety and Applied Nutrition | Food Composition, Standards, Labeling and Econ |
| March 15, 2012 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Tower Laboratories, Ltd.
- FDA Inspection 1264996 - 2025-07-30
- FDA Inspection 1167686 - 2022-04-11
- FDA Inspection 1046208 - 2018-03-23
- FDA Inspection 983675 - 2016-09-01
- FDA Inspection 773285 - 2012-03-15
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