989752
Laboratorios Jaloma S.A. de C.V. — FEI 3002600322
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- September 9, 2016
- Fiscal Year
- 2016
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Guadalajara (Mexico)
Citations
| ID | CFR | Description |
|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1194 | 21 CFR 211.42(c) | Defined areas of adequate size for operations |
| 1395 | 21 CFR 211.103 | Actual vs. theoretical yields not determined |
| 1418 | 21 CFR 211.42(c)(7) | Quarantined Drug Products Area |
| 1505 | 21 CFR 211.122(d) | Label storage access limited to authorized personnel |
| 1790 | 21 CFR 211.80(b) | Handling and Storage to Prevent Contamination |
| 1791 | 21 CFR 211.80(c) | Storage off Floor, Spaced Suitably |
| 1825 | 21 CFR 211.84(c)(6) | Identifying Containers Sampled |
| 1914 | 21 CFR 211.166(a) | Lack of written stability program |
| 1942 | 21 CFR 211.180(e) | Records reviewed annually |
| 1975 | 21 CFR 211.182 | Written records kept in individual logs |
| 2009 | 21 CFR 211.188 | Prepared for each batch, include complete information |
| 2024 | 21 CFR 211.188(b)(12) | Documentation of Batch Investigations |
| 3557 | 21 CFR 211.52 | Washing and toilet facilities are deficient |
| 3559 | 21 CFR 211.56(a) | Sanitation--buildings not clean, free of infestation |
| 4307 | 21 CFR 211.80(d) | Status of Each Lot Identified |
| 4401 | 21 CFR 211.186(b)(9) | Complete instructions, procedures, specifications et. al. |