FDA Inspection
Acme United CorporationAcme United Corporation – FDA Inspection, Mar 8, 2019
Record Details
This FDA Inspection record concerns Acme United Corporation, with an inspection on March 8, 2019, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · 004bdfdb-048d-43b5-928c-b16794d349c3
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1081814
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
5- 21 CFR 211.113(a)Procedures for non-sterile drug products
- 21 CFR 211.67(b)(5)Cleaning SOPs/equipment protection
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.56(c)Written procedures lacking for use of pesticides etc.
- 21 CFR 211.100(b)SOPs not followed / documented
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Other FDA inspections of Acme United Corporation
2| Date | Classification | Office | Project area |
|---|---|---|---|
| March 28, 2025 | OAI | Florida District Office | Drug Quality Assurance |
| May 26, 2017 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
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