FDA Inspection 999631 — Dercher Enterprises, Inc., DBA Gordon Laboratories
The FDA completed an inspection of Dercher Enterprises, Inc., DBA Gordon Laboratories on January 19, 2017 in Upper Darby, PA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 5 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- January 19, 2017
- Fiscal Year
- 2017
- Product Type
- Food/Cosmetics
- Project Area
- Colors and Cosmetics Technology
- Location
- Upper Darby, PA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1361 | 21 CFR 211.100(a) | Absence of Written Procedures |
| 1411 | 21 CFR 211.105(b) | Distinctive ID or code not recorded in batch record |
| 1844 | 21 CFR 211.84(d)(2) | Establish reliability of supplier's C of A |
| 1926 | 21 CFR 211.166(b) | Adequate number of batches on stability |
| 4306 | 21 CFR 211.80(a) | Written Procedures Not Followed |