Warning letter
Mc-NEIL-PPC, Inc.: warning letter of May 22, 2012
FDA warning letter 291938 · New Jersey District Office
Key facts
| Reference number | 291938 |
|---|---|
| Company | Mc-NEIL-PPC, Inc. |
| Subject | Adulterated Device |
| Issue date | May 22, 2012 |
| Posted date | May 22, 2012 |
| Issuing office | New Jersey District Office |
| Product type | Devices |
| CFR sections cited | 803, 803.56, 807.81, 803.50(a)(1), 820 |
| Inspection city | Summit |
| Inspection ZIP | 07901 |
| Inspection start date | Dec 12, 2011 |
| 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: