FDA Inspection 1091328 — CGA Limited
The FDA completed an inspection of CGA Limited on May 31, 2019 in Laventille. 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
- May 31, 2019
- Fiscal Year
- 2019
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Laventille (Trinidad & Tobago)
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 |
| 1395 | 21 CFR 211.103 | Actual vs. theoretical yields not determined |
| 1926 | 21 CFR 211.166(b) | Adequate number of batches on stability |
| 2012 | 21 CFR 211.188(b) | Batch production and Batch Control Record Requirements |
| 2027 | 21 CFR 211.192 | Investigations of discrepancies, failures |
| 3581 | 21 CFR 211.101(d) | Verification of component addition |
| 3582 | 21 CFR 211.105(a) | Identification of containers, lines, equipment |
| 3603 | 21 CFR 211.160(b) | Scientifically sound laboratory controls |
| 3613 | 21 CFR 211.160(b)(4) | Establishment of calibration procedures |