FDA Inspection
Tedor Pharma, Inc.Tedor Pharma, Inc. – FDA Inspection, Jan 31, 2019
Record Details
This FDA Inspection record concerns Tedor Pharma, Inc., with an inspection on January 31, 2019, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · 9b5aa688-b7e6-4e1c-8397-a3e9cf008050
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1077786
- FDA center
- Human Drugs
- Project area
- New Drug Evaluation
- Outcome
- Form 483 issued
FDA Citations
6- 21 CFR 211.160(b)(2)Acceptance of in-process materials
- 21 CFR 211.160(b)(4)Establishment of calibration procedures
- 21 CFR 211.165(e)Test methods
- 21 CFR 211.180(c)Records not made readily available to FDA
- 21 CFR 211.63Equipment Design, Size and Location
- 21 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
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Other FDA inspections of Tedor Pharma, Inc.
4| Date | Classification | Office | Project area |
|---|---|---|---|
| June 5, 2025 | VAI | New England District Office | Drug Quality Assurance |
| April 20, 2017 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| October 29, 2013 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| September 9, 2011 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Tedor Pharma, Inc.
- FDA Inspection 1271887 - 2025-06-05
- FDA Inspection 1010372 - 2017-04-20
- FDA Inspection 853221 - 2013-10-29
- FDA Inspection 743987 - 2011-09-09
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