FDA Inspection 953460 — Morton Drug Company dba Morton LTC
The FDA completed an inspection of Morton Drug Company dba Morton LTC on December 22, 2015 in Neenah, WI. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 7 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- December 22, 2015
- Fiscal Year
- 2016
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Neenah, WI (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1162 | 21 CFR 211.28(a) | Protective Apparel Not Worn |
| 1434 | 21 CFR 211.42(c)(10)(iv) | Environmental Monitoring System |
| 1435 | 21 CFR 211.42(c)(10)(v) | Cleaning System |
| 1436 | 21 CFR 211.42(c)(10)(vi) | Equipment to control conditions |
| 1452 | 21 CFR 211.113(b) | Validation lacking for sterile drug products |
| 3603 | 21 CFR 211.160(b) | Scientifically sound laboratory controls |
| 4357 | 21 CFR 211.166(a) | Results not used for expiration dates, storage cond. |