FDA Inspection 1169023 — Marlinz Pharma, LLC
The FDA completed an inspection of Marlinz Pharma, LLC on May 4, 2022 in Houston, TX. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 2 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- May 4, 2022
- Fiscal Year
- 2022
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Houston, TX (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 2618 | 21 CFR 211.198(b)(1) | Complaint Record required information |
| 4389 | 21 CFR 211.198(a) | Procedures to be written and followed |