FDA Inspection 720665 — Ex-Lax, Inc.
The FDA completed an inspection of Ex-Lax, Inc. on April 27, 2011 in Humacao, PR. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 9 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- April 27, 2011
- Fiscal Year
- 2011
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Humacao, PR (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1213 | 21 CFR 211.67(a) | Cleaning / Sanitizing / Maintenance |
| 1215 | 21 CFR 211.67(b) | Written procedures not established/followed |
| 1395 | 21 CFR 211.103 | Actual vs. theoretical yields not determined |
| 1637 | 21 CFR 211.130(e) | Packaging line inspection after use |
| 1801 | 21 CFR 211.84(a) | Components withheld from use pending release |
| 1803 | 21 CFR 211.84(b) | Representative Samples Criteria |
| 1976 | 21 CFR 211.182 | Specific information required in individual logs |
| 3550 | 21 CFR 211.46(c) | Exhaust systems inadequate to control air contamination |