FDA Inspection
Acme United CorporationAcme United Corporation – FDA Inspection, May 26, 2017
Record Details
This FDA Inspection record concerns Acme United Corporation, with an inspection on May 26, 2017, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · ebb25177-b301-4493-be57-c3346e040b71
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1012163
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
15- 21 CFR 211.103Actual vs. theoretical yields not determined
- 21 CFR 211.56(a)Sanitation--buildings not clean, free of infestation
- 21 CFR 211.137(a)Expiration date lacking
- 21 CFR 211.84(d)(2)Establish reliability of supplier"s C of A
- 21 CFR 211.125(d)Destruction of excess labels with lot numbers
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.194(a)(4)Complete Test Data
- 21 CFR 211.170(b)Annual visual exams of drug products
- 21 CFR 211.68(a)Calibration/Inspection/Checking not done
- 21 CFR 211.42(c)(9)Control / Lab Operations Area
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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 |
| March 8, 2019 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
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