FDA Inspection 1020188 — Mars Fishcare North America, Inc.
The FDA completed an inspection of Mars Fishcare North America, Inc. on Aug 3, 2017 in Chalfont, PA. The inspection was classified OAI (Official Action Indicated — regulatory and/or administrative actions are recommended). 13 citations were issued during this inspection. Product area: Veterinary.
Inspection Details
- Classification
- Official Action Indicated (OAI)
- End Date
- Aug 3, 2017
- Fiscal Year
- 2017
- Product Type
- Veterinary
- Project Area
- Monitoring of Marketed Animal Drugs, Feed, and Devices
- Location
- Chalfont, PA (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 |
| 1215 | 21 CFR 211.67(b) | Written procedures not established/followed |
| 1227 | 21 CFR 211.67(c) | Cleaning/maintenance records not kept |
| 1361 | 21 CFR 211.100(a) | Absence of Written Procedures |
| 1540 | 21 CFR 211.125(a) | Strict control not exercised over labeling issued |
| 1883 | 21 CFR 211.165(a) | Testing and release for distribution |
| 1914 | 21 CFR 211.166(a) | Lack of written stability program |
| 1943 | 21 CFR 211.180(e)(1) | Review of representative number of batches |
| 3583 | 21 CFR 211.110(a) | Written in-process control procedures |
| 3632 | 21 CFR 211.170(b) | Annual visual exams of drug products |
| 4314 | 21 CFR 211.84(d)(2) | Reports of Analysis (Components) |
| 4380 | 21 CFR 211.198(b)(3) | Determination not to conduct investigation of complaint |