FDA Inspection 1050276 — Dr Marcs Manufacturing And Sales, LLC
The FDA completed an inspection of Dr Marcs Manufacturing And Sales, LLC on Apr 27, 2018 in North Hills, CA. The inspection was classified OAI (Official Action Indicated — regulatory and/or administrative actions are recommended). 8 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI)
- End Date
- Apr 27, 2018
- Fiscal Year
- 2018
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- North Hills, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1111 | 21 CFR 211.25(a) | Training , Education , Experience overall |
| 1787 | 21 CFR 211.80(a) | Procedures To Be in Writing |
| 1914 | 21 CFR 211.166(a) | Lack of written stability program |
| 2419 | 21 CFR 211.198(a) | Complaint Handling Procedure |
| 4336 | 21 CFR 211.150 | Written distribution procedure |
| 4342 | 21 CFR 211.142(b) | Storage under appropriate conditions |
| 4359 | 21 CFR 211.170(b)(1) | Retention time of reserve samples, in general |
| 9001 | 21 CFR 211.22(a) | Lack of quality control unit |