FDA Inspection
Granules USA, Inc.Granules USA, Inc. – FDA Inspection, Dec 20, 2016
Record Details
This FDA Inspection record concerns Granules USA, Inc., with an inspection on December 20, 2016, issued by the New Jersey District Office, covering human drugs.
- Person
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ID · f368786f-7b24-4761-b41d-697defec63a8
Inspection Facts
- Inspection number
- 997063
- FDA center
- Human Drugs
- Project area
- Postmarket Surv. and Epidemiology
- Outcome
- Form 483 issued
FDA Citations
6- 21 CFR 314.80(b)Failure to develop written procedures
- 21 CFR 314.80(c)(2)Late submission of annual safety reports
- 21 CFR 314.80(c)(2)Late submission of quarterly safety reports
- 21 CFR 314.80(c)(2)(ii)(A)Incomplete periodic safety report
- 21 CFR 314.80(g)(1)Failure to submit electronic format safety report
- 21 CFR 314.81(b)(2)Timely submission
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