Warning letter
Swabplus, L.P.: warning letter of Oct 31, 2019
FDA warning letter 584803 · Division of Pharmaceutical Quality Operations IV
Key facts
| Reference number | 584803 |
|---|---|
| Company | Swabplus, L.P. |
| Subject | CGMP/Finished Pharmaceuticals/Adulterated |
| Issue date | Oct 31, 2019 |
| Posted date | Nov 12, 2019 |
| Issuing office | Division of Pharmaceutical Quality Operations IV |
| Product type | Drugs |
| CFR sections cited | 211.165(b), 211.22(a), 211.68(b), 211.84(d)(1) |
| Inspection city | Rancho Cucamonga |
| Inspection ZIP | 91730 |
| Inspection start date | Mar 19, 2019 |
| Letter on fda.gov | fda.gov |
At a glance
- 1–9 CFR sections cited
- OAI Linked inspection classification
- Yes Form FDA 483 issued
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA warning letters
FDA warning letters notify a firm of significant regulatory violations found during an inspection or review and request prompt corrective action.
Source: U.S. Food and Drug Administration (FDA), Warning Letters · Source date: