FDA Inspection 729754 — RXW CGMP, LLC
The FDA completed an inspection of RXW CGMP, LLC on June 28, 2011 in Dearborn, MI. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 8 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- June 28, 2011
- Fiscal Year
- 2011
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- Dearborn, MI (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15493 | 21 CFR 111.25(b) | Procedures - calibrating automated, mechanical equip |
| 15494 | 21 CFR 111.25(c) | Procedures - equipment - cleaning, sanitizing |
| 15570 | 21 CFR 111.153 | Written procedures - components |
| 15583 | 21 CFR 111.155(d)(1) | Components - identify lot received |
| 15796 | 21 CFR 111.430(b) | Records - packaging, labeling operations |
| 15858 | 21 CFR 111.75(a)(1)(i) | Component - verify identity, dietary ingredient |
| 15871 | 21 CFR 111.75(c)(2) | Specifications met - test, examinations; compliance |
| 16072 | 21 CFR 111.35(b)(3) | Instruments, controls; calibrate date, reference std, method |