FDA Inspection 1240391 — Warner Graham LLLP
The FDA completed an inspection of Warner Graham LLLP on May 21, 2024 in Cockeysville, MD. 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). 6 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- May 21, 2024
- Fiscal Year
- 2024
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Cockeysville, MD (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1220 | 21 CFR 211.67(b)(3) | Cleaning SOPs/instructions |
| 1361 | 21 CFR 211.100(a) | Absence of Written Procedures |
| 1450 | 21 CFR 211.113(a) | Procedures for non-sterile drug products |
| 1914 | 21 CFR 211.166(a) | Lack of written stability program |
| 4401 | 21 CFR 211.186(b)(9) | Complete instructions, procedures, specifications et. al. |