Granules
Form 483 issued December 9, 2016
- Observations
- 7
- Pages
- 4
- FEI number
- 3012806860
In short: On December 9, 2016, FDA issued a Form 483 with 7 observations to Granules (FEI 3012806860).
What FDA observed
Preview: the opening words of each observation- 01
The Quality Unit cannot ensure the review of all deviation reported during production prior to…
- 02
Employce was not trained prior to conducting the cleaning of the Microbiology Laboratory…
- 03
Change Control system does not evaluate and reflect all changes that may affect the production…
- 04
Production Master Batch Records…
This inspection in context
Questions about this 483
What did FDA find at Granules?
FDA listed 7 observations on this Form 483. The opening words of each observation are shown on this page.
When was Granules inspected by FDA?
This Form 483 is dated December 9, 2016.
How do I get the full Form 483 for Granules?
Download the original PDF from FDA Intel for $99, with no subscription. Your first Form 483 or letter is on us. You also get an invoice PDF with the order.