Warning letter
Jacobs Pills, Inc.: warning letter of May 31, 2018
FDA warning letter 534441 · New Jersey District Office
Key facts
| Reference number | 534441 |
|---|---|
| Company | Jacobs Pills, Inc. |
| Subject | Compounding Pharmacy/Adulterated Drug Products |
| Issue date | May 31, 2018 |
| Posted date | Jul 3, 2018 |
| Issuing office | New Jersey District Office |
| Product type | Drugs |
| CFR sections cited | 201.115, 200.10(b), 211.110(a), 210.1(b), 211.84(e), 211.137(a) |
| Inspection city | Elmsford |
| Inspection ZIP | 10523 |
| Inspection start date | Feb 22, 2017 |
| 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: