FDA Inspection 583384 — ARG Laboratories, Inc.
The FDA completed an inspection of ARG Laboratories, Inc. on May 15, 2009 in Dallas, TX. The inspection was classified NAI (No Action Indicated — no objectionable conditions were found). 16 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- No Action Indicated (NAI) (NAI)
- End Date
- May 15, 2009
- Fiscal Year
- 2009
- Product Type
- Food/Cosmetics
- Project Area
- Colors and Cosmetics Technology
- Location
- Dallas, TX (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1111 | 21 CFR 211.25(a) | Training , Education , Experience overall |
| 1361 | 21 CFR 211.100(a) | Absence of Written Procedures |
| 1550 | 21 CFR 211.125(f) | Procedures Written and Followed |
| 1767 | 21 CFR 211.137(a) | Expiration date lacking |
| 2008 | 21 CFR 211.186(a) | Written procedures followed |
| 2009 | 21 CFR 211.188 | Prepared for each batch, include complete information |
| 2031 | 21 CFR 211.194(a) | Complete test data included in records |
| 3565 | 21 CFR 211.58 | Buildings not maintained in good state of repair |
| 3585 | 21 CFR 211.110(a) | Control procedures to monitor and validate performance |
| 4314 | 21 CFR 211.84(d)(2) | Reports of Analysis (Components) |
| 4328 | 21 CFR 211.122(a) | Written procedures not followed |
| 4343 | 21 CFR 211.160(b)(1) | Incoming lots - conformance to written specs- |
| 4344 | 21 CFR 211.160(b)(1) | Sampling and testing procedures described |
| 4350 | 21 CFR 211.160(b)(3) | Drug products-sampling procedures/specifications |
| 4352 | 21 CFR 211.160(b)(4) | Calibration - at intervals, written program, remedial action |
| 4576 | 21 CFR 211.192 | No written record of investigation |