FDA Inspection 586490 — Tropichem Research Labs LLC
The FDA completed an inspection of Tropichem Research Labs LLC on May 29, 2009 in Jupiter, FL. 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). 15 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- May 29, 2009
- Fiscal Year
- 2009
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Jupiter, FL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1098 | 21 CFR 211.22(c) | Approve or reject procedures or specs |
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1133 | 21 CFR 211.25(a) | GMP Training Frequency |
| 1220 | 21 CFR 211.67(b)(3) | Cleaning SOPs/instructions |
| 1395 | 21 CFR 211.103 | Actual vs. theoretical yields not determined |
| 1883 | 21 CFR 211.165(a) | Testing and release for distribution |
| 1943 | 21 CFR 211.180(e)(1) | Review of representative number of batches |
| 2008 | 21 CFR 211.186(a) | Written procedures followed |
| 2009 | 21 CFR 211.188 | Prepared for each batch, include complete information |
| 3570 | 21 CFR 211.100(a) | Approval and review of procedures |
| 3571 | 21 CFR 211.100(a) | Changes to Procedures Not Reviewed, Approved |
| 3573 | 21 CFR 211.101(b) | Measured components for manufacturing |
| 3603 | 21 CFR 211.160(b) | Scientifically sound laboratory controls |
| 3616 | 21 CFR 211.165(d) | Acceptance criteria for sampling & testing |
| 4303 | 21 CFR 211.67(b) | Written procedures fail to include |