FDA Inspection 773554 — Aloe Science Laboratories, Inc
The FDA completed an inspection of Aloe Science Laboratories, Inc on March 9, 2012 in Garland, TX. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 24 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- March 9, 2012
- Fiscal Year
- 2012
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Garland, TX (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1133 | 21 CFR 211.25(a) | GMP Training Frequency |
| 1361 | 21 CFR 211.100(a) | Absence of Written Procedures |
| 15410 | 21 CFR 111.14(b)(2) | Personnel - records - training |
| 15434 | 21 CFR 111.15(d)(2) | Pest control measures |
| 15492 | 21 CFR 111.25(a) | Procedures - calibrating instruments |
| 15566 | 21 CFR 111.260(l)(3) | Batch record - approved, released, rejected; batch |
| 15570 | 21 CFR 111.153 | Written procedures - components |
| 15737 | 21 CFR 111.210(h)(5) | Corrective action plans |
| 15744 | 21 CFR 111.210(h)(2) | Master manufacturing record - sampling, tests, examinations |
| 15745 | 21 CFR 111.210(h)(1) | Instructions; specifications; packaged, labeled |
| 15747 | 21 CFR 111.210(g) | Packaging description, representative label |
| 15748 | 21 CFR 111.210(f) | Master manufacturing record theoretical and expected yield |
| 15751 | 21 CFR 111.210(d) | Master manufacturing record - Supplemental Facts |
| 15825 | 21 CFR 111.65 | Quality control - quality, dietary supplement |
| 15839 | 21 CFR 111.70(e) | Specifications - identity, purity, strength, composition |
| 15858 | 21 CFR 111.75(a)(1)(i) | Component - verify identity, dietary ingredient |
| 16070 | 21 CFR 111.35(b)(2) | Document-equipment date of use, maintain, clean, sanitize |
| 16071 | 21 CFR 111.35(b)(3) | Documentation - instruments, controls; calibrations |
| 1787 | 21 CFR 211.80(a) | Procedures To Be in Writing |
| 1975 | 21 CFR 211.182 | Written records kept in individual logs |
| 2026 | 21 CFR 211.192 | Quality control unit review of records |
| 2419 | 21 CFR 211.198(a) | Complaint Handling Procedure |
| 3559 | 21 CFR 211.56(a) | Sanitation--buildings not clean, free of infestation |
| 9001 | 21 CFR 211.22(a) | Lack of quality control unit |