FDA Inspection 713308 — Irenda Corporation
The FDA completed an inspection of Irenda Corporation on March 4, 2011 in Los Angeles, CA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 25 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- March 4, 2011
- Fiscal Year
- 2011
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- Los Angeles, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1177 | 21 CFR 211.63 | Equipment Design, Size and Location |
| 15437 | 21 CFR 111.15(a)(1) | Grounds - equipment, litter, weeds |
| 15443 | 21 CFR 111.15(b)(2) | Physical plant - repair |
| 15624 | 21 CFR 111.180(b)(3) | Documentation - components |
| 15645 | 21 CFR 111.455(c) | Hold - mix-up, contamination, deterioration |
| 15665 | 21 CFR 111.303 | Written procedures - tests, examinations; specifications met |
| 15861 | 21 CFR 111.75(a)(2)(ii)(A) | Component - qualify supplier |
| 15892 | 21 CFR 111.80(b) | Specifications - representative samples; in-process material |
| 15911 | 21 CFR 111.90(b)(1) | In-process adjustment, component - no material review |
| 15935 | 21 CFR 111.105(d) | Quality control - basis; tests, examinations |
| 16040 | 21 CFR 111.610(a) | Records - available; FDA |
| 1885 | 21 CFR 211.165(b) | Microbiological testing |
| 1912 | 21 CFR 211.166(a) | Written program not followed |
| 2031 | 21 CFR 211.194(a) | Complete test data included in records |
| 3559 | 21 CFR 211.56(a) | Sanitation--buildings not clean, free of infestation |
| 3571 | 21 CFR 211.100(a) | Changes to Procedures Not Reviewed, Approved |
| 3603 | 21 CFR 211.160(b) | Scientifically sound laboratory controls |
| 3610 | 21 CFR 211.160(b)(3) | Drug product sample |
| 4310 | 21 CFR 211.84(c)(3) | Sterile Equipment, Aseptic Techniques in sample collecting |
| 4314 | 21 CFR 211.84(d)(2) | Reports of Analysis (Components) |
| 4352 | 21 CFR 211.160(b)(4) | Calibration - at intervals, written program, remedial action |
| 4391 | 21 CFR 211.180(e)(2) | Items to cover on annual reviews |
| 4418 | 21 CFR 211.42(b) | Adequate space lacking to prevent mix-ups and contamination |
| 4576 | 21 CFR 211.192 | No written record of investigation |