FDA Inspection
Thatcher Company, Inc.Thatcher Company, Inc. – FDA Inspection, Dec 10, 2015
Record Details
This FDA Inspection record concerns Thatcher Company, Inc., with an inspection on December 10, 2015, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Thatcher Company, Inc.
- Inspection Date
- December 10, 2015
- Product Type
- Drugs
View Company Profile
ID · 25a24783-2b44-40d8-b7cc-b8fd244df279
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 977465
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
7- 21 CFR 211.68(b)Computer control of master formula records
- 21 CFR 211.110(a)Control procedures to monitor and validate performance
- 21 CFR 211.165(b)Microbiological testing
- 21 CFR 211.160(b)(2)In-process sample representation/identification
- 21 CFR 211.46(c)Air filtration system lacking in production area
- 21 CFR 211.130(a)Prevention of cross contamination, mix-ups
- 21 CFR 211.67(b)Written procedures fail to include
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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 |
| September 18, 2018 | 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 1067393 - 2018-09-18
- FDA Inspection 790878 - 2012-05-24
- FDA Inspection 740198 - 2011-08-12
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