FDA Inspection 782419 — Oh So Clean, Inc. dba CleanWell Company
The FDA completed an inspection of Oh So Clean, Inc. dba CleanWell Company on May 18, 2012 in San Francisco, CA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 3 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- May 18, 2012
- Fiscal Year
- 2012
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- San Francisco, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1361 | 21 CFR 211.100(a) | Absence of Written Procedures |
| 1922 | 21 CFR 211.166(a)(4) | Testing in same container - closure system |
| 2619 | 21 CFR 211.198(b)(2) | Complaint Investigation/Follow-Up Findings |