FDA Inspection 1072541 — Downing Labs, LLC
The FDA completed an inspection of Downing Labs, LLC on November 19, 2018 in Dallas, TX. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 4 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- November 19, 2018
- Fiscal Year
- 2019
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Dallas, TX (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 18956 | FDCA 501(a)(2)(A) | Cleanliness, ISO-classified areas |
| 18960 | FDCA 501(a)(2)(A) | Flow of personnel and materials, facility |
| 18973 | FDCA 501(a)(2)(A) | Disinfecting materials, aseptic processing area |
| 4357 | 21 CFR 211.166(a) | Results not used for expiration dates, storage cond. |