FDA Inspection 1077545 — PLD Acquisitions LLC
The FDA completed an inspection of PLD Acquisitions LLC on January 30, 2019 in Doral, FL. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 5 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- January 30, 2019
- Fiscal Year
- 2019
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Doral, FL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1194 | 21 CFR 211.42(c) | Defined areas of adequate size for operations |
| 1215 | 21 CFR 211.67(b) | Written procedures not established/followed |
| 1219 | 21 CFR 211.67(b)(2) | Cleaning SOPs/schedules |
| 2027 | 21 CFR 211.192 | Investigations of discrepancies, failures |