Warning letter
Bershtel Enterprises LLC dba WePackItAll: warning letter of May 2, 2019
FDA warning letter 570885 · Division of Pharmaceutical Quality Operations IV
Key facts
| Reference number | 570885 |
|---|---|
| Company | Bershtel Enterprises LLC dba WePackItAll |
| Subject | CGMP/Finished Pharmaceuticals/Adulterated |
| Issue date | May 2, 2019 |
| Posted date | May 14, 2019 |
| Issuing office | Division of Pharmaceutical Quality Operations IV |
| Product type | Drugs |
| CFR sections cited | 211.180(e), 211.34, 211.192, 211.113(b) |
| Inspection city | Duarte |
| Inspection ZIP | 91010 |
| Inspection start date | Oct 15, 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: