Warning letter
AMRI Burlington, Inc. (formerly Hyaluron, Inc.) [ARCHIVED]: warning letter of Aug 17, 2010
FDA warning letter 107145 · New England District Office
Key facts
| Reference number | 107145 |
|---|---|
| Company | AMRI Burlington, Inc. (formerly Hyaluron, Inc.) [ARCHIVED] |
| Subject | Current Good Manufacturing Practice for Finished Pharmaceuticals/Adulterated |
| Issue date | Aug 17, 2010 |
| Posted date | Aug 17, 2010 |
| Issuing office | New England District Office |
| Product type | Drugs |
| CFR sections cited | 211.192, 211.110(b), 211.113(b) |
| Inspection city | Burlington |
| Inspection ZIP | 01803 |
| Inspection start date | Mar 2, 2010 |
| 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: