FDA Inspection 609615 — General Organics
The FDA completed an inspection of General Organics on Sep 3, 2009 in Chicago, IL. 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). 14 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Sep 3, 2009
- Fiscal Year
- 2009
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Chicago, IL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1086 | 21 CFR 211.22(b) | Adequate lab facilities not available |
| 1112 | 21 CFR 211.25(a) | Training--operations, GMPs, written procedures |
| 1361 | 21 CFR 211.100(a) | Absence of Written Procedures |
| 1632 | 21 CFR 211.130(c) | Lot or control number assigned |
| 1787 | 21 CFR 211.80(a) | Procedures To Be in Writing |
| 1798 | 21 CFR 211.82(b) | Quarantine Storage of Components |
| 1883 | 21 CFR 211.165(a) | Testing and release for distribution |
| 2009 | 21 CFR 211.188 | Prepared for each batch, include complete information |
| 2419 | 21 CFR 211.198(a) | Complaint Handling Procedure |
| 3557 | 21 CFR 211.52 | Washing and toilet facilities are deficient |
| 3559 | 21 CFR 211.56(a) | Sanitation--buildings not clean, free of infestation |
| 3562 | 21 CFR 211.56(c) | Written procedures lacking for use of pesticides etc. |
| 3632 | 21 CFR 211.170(b) | Annual visual exams of drug products |
| 4314 | 21 CFR 211.84(d)(2) | Reports of Analysis (Components) |