FDA Inspection
Enzyme Solutions, Inc.Enzyme Solutions, Inc. – FDA Inspection, Oct 31, 2012
Record Details
This FDA Inspection record concerns Enzyme Solutions, Inc., with an inspection on October 31, 2012, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Enzyme Solutions, Inc.
- Inspection Date
- October 31, 2012
- Product Type
- Drugs
View Company Profile
ID · 6ea3027f-b33e-49af-9cdd-28acbced7ddf
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 805410
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
9- 21 CFR 211.100(b)Procedure Deviations Recorded and Justified
- 21 CFR 211.160(b)(3)Drug product sample
- 21 CFR 211.165(b)Microbiological testing
- 21 CFR 211.25(a)GMP Training Frequency
- 21 CFR 211.84(d)(2)Reports of Analysis (Components)
- 21 CFR 211.170(b)Annual visual exams of drug products
- 21 CFR 211.165(a)Testing and release for distribution
- 21 CFR 211.160(b)(4)Calibration - at intervals, written program, remedial action
- 21 CFR 211.67(b)Written procedures not established/followed
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Other FDA inspections of Enzyme Solutions, Inc.
3| Date | Classification | Office | Project area |
|---|---|---|---|
| February 23, 2024 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| September 14, 2016 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| May 7, 2010 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Enzyme Solutions, Inc.
- FDA Inspection 1231698 - 2024-02-23
- FDA Inspection 988707 - 2016-09-14
- FDA Inspection 661662 - 2010-05-07
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