FDA Inspection 613995 — Coats Aloe International, Inc.
The FDA completed an inspection of Coats Aloe International, Inc. on September 18, 2009 in Dallas, TX. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 22 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- September 18, 2009
- Fiscal Year
- 2009
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- Dallas, TX (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15395 | 21 CFR 111.10(b)(5) | Gloves |
| 15425 | 21 CFR 111.15(i) | Hand-washing facilities |
| 15447 | 21 CFR 111.15(c)(3) | Cleaning compounds and toxic materials - holding |
| 15467 | 21 CFR 111.20(c)(1) | Physical plant - receiving, holding, identifying |
| 15494 | 21 CFR 111.25(c) | Procedures - equipment - cleaning, sanitizing |
| 15498 | 21 CFR 111.27(d) | Equipment - maintain, clean, sanitize |
| 15505 | 21 CFR 111.27(a)(3)(v) | Equipment - protect from contamination |
| 15546 | 21 CFR 111.260(f) | Batch record - yield |
| 15567 | 21 CFR 111.260(l)(4) | Batch record - approved, released, rejected |
| 15598 | 21 CFR 111.160(d)(1) | Packaging - identify |
| 15624 | 21 CFR 111.180(b)(3) | Documentation - components |
| 15665 | 21 CFR 111.303 | Written procedures - tests, examinations; specifications met |
| 15698 | 21 CFR 111.320(a) | Examination, testing; appropriate |
| 15712 | 21 CFR 111.325(b)(2)(ii) | Records - document; results |
| 15737 | 21 CFR 111.210(h)(5) | Corrective action plans |
| 15739 | 21 CFR 111.210(h)(3)(ii)(B) | Components; add, verify |
| 15748 | 21 CFR 111.210(f) | Master manufacturing record theoretical and expected yield |
| 15858 | 21 CFR 111.75(a)(1)(i) | Component - verify identity, dietary ingredient |
| 15922 | 21 CFR 111.95(b)(3) | Documentation - ensure specifications met |
| 15923 | 21 CFR 111.95(b)(4) | Documentation - specifications met; test, examinations |
| 15967 | 21 CFR 111.117(b) | Quality control operations - calibration records |
| 16057 | 21 CFR 111.535(b)(1) | Records - returned dietary supplement: written procedures |