Warning letter
B & B Pharmaceuticals, Inc.: warning letter of Jun 4, 2019
FDA warning letter 570613 · Division of Pharmaceutical Quality Operations IV
Key facts
| Reference number | 570613 |
|---|---|
| Company | B & B Pharmaceuticals, Inc. |
| Subject | Unapproved New Drug/Misbranded |
| Issue date | Jun 4, 2019 |
| Posted date | Jul 2, 2019 |
| Issuing office | Division of Pharmaceutical Quality Operations IV |
| Product type | Drugs |
| CFR sections cited | 207.17 |
| Inspection city | Englewood |
| Inspection ZIP | 80112 |
| Inspection start date | Oct 17, 2018 |
| 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: