FDA Inspection 730590 — JDJMM Enterprises
The FDA completed an inspection of JDJMM Enterprises on July 8, 2011 in Spring, TX. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 15 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- July 8, 2011
- Fiscal Year
- 2011
- Product Type
- Drugs
- Project Area
- Unapproved and Misbranded Drugs
- Location
- Spring, TX (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15380 | 21 CFR 111.8 | Written procedures - sick or infected personnel |
| 15381 | 21 CFR 111.8 | Written procedures - hygienic practices |
| 15382 | 21 CFR 111.8 | Written procedures - personnel qualifications |
| 15481 | 21 CFR 111.23(b) | Records - cleaning, pest control |
| 15494 | 21 CFR 111.25(c) | Procedures - equipment - cleaning, sanitizing |
| 15576 | 21 CFR 111.155(a) | Visually examine - containers |
| 15604 | 21 CFR 111.165(b) | Product received - visually examine invoice, guarantee, cert |
| 15641 | 21 CFR 111.453 | Written procedures - holding |
| 15797 | 21 CFR 111.553 | Written procedures - product complaint |
| 15819 | 21 CFR 111.55 | Production, process controls - implement |
| 15826 | 21 CFR 111.65 | Quality control - packaged, labeled |
| 15842 | 21 CFR 111.70(f) | Specifications - product received for packaging, labeling |
| 15897 | 21 CFR 111.83(a) | Reserve sample - collect, hold |
| 15927 | 21 CFR 111.103 | Written procedures - quality control operations |
| 16042 | 21 CFR 111.503 | Written procedures - returned dietary supplement |