FDA Inspection 618309 — Puerto Rico Beverage Inc
The FDA completed an inspection of Puerto Rico Beverage Inc on September 28, 2009 in Maunabo, PR. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 16 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- September 28, 2009
- Fiscal Year
- 2009
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Maunabo, PR (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1112 | 21 CFR 211.25(a) | Training--operations, GMPs, written procedures |
| 1134 | 21 CFR 211.25(b) | Supervisor Training/Education/Experience |
| 1172 | 21 CFR 110.40(e) | Lack of thermometer |
| 1361 | 21 CFR 211.100(a) | Absence of Written Procedures |
| 1495 | 21 CFR 211.122(a) | Written procedures describing in detail |
| 1560 | 21 CFR 110.35(c) | Lack of effective pest exclusion |
| 1767 | 21 CFR 211.137(a) | Expiration date lacking |
| 1787 | 21 CFR 211.80(a) | Procedures To Be in Writing |
| 1885 | 21 CFR 211.165(b) | Microbiological testing |
| 3565 | 21 CFR 211.58 | Buildings not maintained in good state of repair |
| 3611 | 21 CFR 211.160(b)(3) | Acceptance of drug products |
| 3661 | 21 CFR 110.37(e)(5) | Signs |
| 4303 | 21 CFR 211.67(b) | Written procedures fail to include |
| 4336 | 21 CFR 211.150 | Written distribution procedure |
| 4389 | 21 CFR 211.198(a) | Procedures to be written and followed |
| 9001 | 21 CFR 211.22(a) | Lack of quality control unit |