FDA Inspection
Thatcher Company, Inc.Thatcher Company, Inc. – FDA Inspection, Sep 18, 2018
Record Details
This FDA Inspection record concerns Thatcher Company, Inc., with an inspection on September 18, 2018, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · 35e7160a-2269-40e2-a35e-5d6dbbeee35c
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1067393
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
4- 21 CFR 211.68(b)Computer control of master formula records
- 21 CFR 211.100(b)Procedure Deviations Recorded and Justified
- 21 CFR 211.165(b)Microbiological testing
- 21 CFR 211.67(b)(4)Cleaning SOPs/equipment identification
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Other FDA inspections of Thatcher Company, Inc.
5| Date | Classification | Office | Project area |
|---|---|---|---|
| September 17, 2025 | Not classified | Denver District Office | |
| October 23, 2019 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| December 10, 2015 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| May 24, 2012 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| August 12, 2011 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Thatcher Company, Inc.
- FDA Inspection 1283408 - 2025-09-17
- FDA Inspection 1111900 - 2019-10-23
- FDA Inspection 977465 - 2015-12-10
- FDA Inspection 790878 - 2012-05-24
- FDA Inspection 740198 - 2011-08-12
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