Warning letter
I.V. Specialty, Ltd: warning letter of Apr 21, 2015
FDA warning letter 449528 · Dallas District Office
Key facts
| Reference number | 449528 |
|---|---|
| Company | I.V. Specialty, Ltd |
| Subject | Drug/Prepared, Packed or Held Under Insanitary Conditions/Adulterated |
| Issue date | Apr 21, 2015 |
| Posted date | Jun 9, 2015 |
| Issuing office | Dallas District Office |
| Product type | Drugs |
| CFR sections cited | 201.115, 211.28(a), 211.42(c)(10)(iv), 211.42(c)(10)(v), 211.42(c)(10)(vi), 211.167(a), 211.113(b) |
| Inspection city | Austin |
| Inspection ZIP | 78757 |
| Inspection start date | Jul 14, 2014 |
| Letter on fda.gov | web.archive.org |
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: