FDA Inspection 1091897 — Schlotterbeck & Foss, LLC
The FDA completed an inspection of Schlotterbeck & Foss, LLC on June 4, 2019 in Westbrook, ME. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 9 citations were issued during this inspection. Product area: Veterinary.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- June 4, 2019
- Fiscal Year
- 2019
- Product Type
- Veterinary
- Project Area
- Monitoring of Marketed Animal Drugs, Feed, and Devices
- Location
- Westbrook, ME (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1112 | 21 CFR 211.25(a) | Training--operations, GMPs, written procedures |
| 1213 | 21 CFR 211.67(a) | Cleaning / Sanitizing / Maintenance |
| 1361 | 21 CFR 211.100(a) | Absence of Written Procedures |
| 1842 | 21 CFR 211.84(d)(1) | Component identity verification |
| 1849 | 21 CFR 211.84(d)(6) | Objectionable microbiological contamination |
| 2027 | 21 CFR 211.192 | Investigations of discrepancies, failures |
| 2203 | 21 CFR 211.186(b)(7) | Theoretical Yield and Percentages |
| 3591 | 21 CFR 211.110(b) | In-process materials specifications |
| 4372 | 21 CFR 211.188(b)(8) | Labeling control records including specimens or copies |