FDA Inspection 772963 — H & L Jerch Sales, Inc.
The FDA completed an inspection of H & L Jerch Sales, Inc. on March 14, 2012 in South Haven, MI. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 10 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- March 14, 2012
- Fiscal Year
- 2012
- Product Type
- Drugs
- Project Area
- Unapproved and Misbranded Drugs
- Location
- South Haven, MI (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1495 | 21 CFR 211.122(a) | Written procedures describing in detail |
| 15659 | 21 CFR 111.475(b)(1) | Written procedures - holding; distributing |
| 15774 | 21 CFR 111.415(f)(1) | Batch-lot,control number packaged, labeled dietary supplemen |
| 15796 | 21 CFR 111.430(b) | Records - packaging, labeling operations |
| 15797 | 21 CFR 111.553 | Written procedures - product complaint |
| 15989 | 21 CFR 111.127 | Quality control operations - packaging, labeling |
| 16013 | 21 CFR 111.140(b)(1) | Records - quality control operations; responsibilities |
| 1626 | 21 CFR 211.130 | Procedures are written, and followed |
| 1777 | 21 CFR 211.150(b) | Distribution Recall System |
| 9001 | 21 CFR 211.22(a) | Lack of quality control unit |