FDA Inspection 772380 — EMCO Chemical Distributors., Inc.
The FDA completed an inspection of EMCO Chemical Distributors., Inc. on Mar 22, 2012 in North 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). 8 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Mar 22, 2012
- Fiscal Year
- 2012
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- North Chicago, IL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1049 | 21 CFR 211.22(a) | Approve or reject components, products |
| 1361 | 21 CFR 211.100(a) | Absence of Written Procedures |
| 1550 | 21 CFR 211.125(f) | Procedures Written and Followed |
| 1787 | 21 CFR 211.80(a) | Procedures To Be in Writing |
| 2008 | 21 CFR 211.186(a) | Written procedures followed |
| 2026 | 21 CFR 211.192 | Quality control unit review of records |
| 3561 | 21 CFR 211.56(b) | Written sanitation procedures lacking |
| 4336 | 21 CFR 211.150 | Written distribution procedure |