FDA Inspection
Ironwood Clay Company IncIronwood Clay Company Inc – FDA Inspection, Jul 20, 2017
Record Details
This FDA Inspection record concerns Ironwood Clay Company Inc, with an inspection on July 20, 2017, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · 78877c8f-e1b3-44f3-9225-1fe91f349bca
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1023447
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
5- 21 CFR 211.25(a)GMP Training Frequency
- 21 CFR 211.68(b)input/output verification
- 21 CFR 211.100(a)Absence of Written Procedures
- 21 CFR 211.166(a)Lack of written stability program
- 21 CFR 211.67(b)Written procedures not established/followed
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Other FDA inspections of Ironwood Clay Company Inc
1| Date | Classification | Office | Project area |
|---|---|---|---|
| June 16, 2022 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Ironwood Clay Company Inc
- FDA Inspection 1174388 - 2022-06-16
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