FDA Inspection
Enzyme Solutions, Inc.Enzyme Solutions, Inc. – FDA Inspection, May 7, 2010
Record Details
This FDA Inspection record concerns Enzyme Solutions, Inc., with an inspection on May 7, 2010, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Enzyme Solutions, Inc.
- Inspection Date
- May 7, 2010
- Product Type
- Drugs
View Company Profile
ID · 245c1b36-0566-4f8b-abe3-0bf871c8d1c2
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 661662
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
13- 21 CFR 211.103Actual vs. theoretical yields not determined
- 21 CFR 211.188(b)(2)Identity of major equipment and lines used
- 21 CFR 211.188(b)(3)Identification of each component or in-process material
- 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 211.194(d)Laboratory equipment calibration records
- 21 CFR 211.84(d)(2)Reports of Analysis (Components)
- 21 CFR 211.165(a)Testing and release for distribution
- 21 CFR 211.160(b)(4)Calibration - at intervals, written program, remedial action
Showing 10 of 13 citations.
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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 |
| October 31, 2012 | 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 805410 - 2012-10-31
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