FDA Inspection 661662 — Enzyme Solutions, Inc.
The FDA completed an inspection of Enzyme Solutions, Inc. on May 7, 2010 in Garrett, IN. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 13 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- May 7, 2010
- Fiscal Year
- 2010
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Garrett, IN (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1215 | 21 CFR 211.67(b) | Written procedures not established/followed |
| 1395 | 21 CFR 211.103 | Actual vs. theoretical yields not determined |
| 1883 | 21 CFR 211.165(a) | Testing and release for distribution |
| 1885 | 21 CFR 211.165(b) | Microbiological testing |
| 1975 | 21 CFR 211.182 | Written records kept in individual logs |
| 2034 | 21 CFR 211.194(d) | Laboratory equipment calibration records |
| 3572 | 21 CFR 211.100(b) | Procedure Deviations Recorded and Justified |
| 3610 | 21 CFR 211.160(b)(3) | Drug product sample |
| 4314 | 21 CFR 211.84(d)(2) | Reports of Analysis (Components) |
| 4352 | 21 CFR 211.160(b)(4) | Calibration - at intervals, written program, remedial action |
| 4377 | 21 CFR 211.188(b)(3) | Identification of each component or in-process material |
| 4378 | 21 CFR 211.188(b)(2) | Identity of major equipment and lines used |