FDA Inspection 1050276 — Dr Marcs Manufacturing and Sales, LLC
The FDA completed an inspection of Dr Marcs Manufacturing and Sales, LLC on April 27, 2018 in North Hills, CA. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 8 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- April 27, 2018
- Fiscal Year
- 2018
- Product Type
- Food/Cosmetics
- Project Area
- Colors and Cosmetics Technology
- 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 |