FDA Inspection
EXACT SCIENTIFIC SERVICES, INC.EXACT SCIENTIFIC SERVICES, INC. – FDA Inspection, Jun 3, 2021
Record Details
This FDA Inspection record concerns EXACT SCIENTIFIC SERVICES, INC., with an inspection on June 3, 2021, issued by the Center for Veterinary Medicine, covering veterinary.
- Inspection Date
- June 3, 2021
- Product Type
- Veterinary
View Company Profile
ID · c4e100df-8111-46e9-b6fc-fdaf8e802ef8
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1143847
- FDA center
- Animal Drugs & Feeds
- Project area
- Pre-Approval Eval. of Animal Drugs and Food Additives
FDA Citations
5- 21 CFR 211.165(d)Acceptance criteria for sampling & testing
- 21 CFR 211.68(b)input/output verification
- 21 CFR 211.194(a)(8)Second person sign off
- 21 CFR 211.165(e)Test methods
- 21 CFR 211.22(d)Procedures not in writing, fully followed
Full citation text and observation details available on the Dashboard.
Other FDA inspections of EXACT SCIENTIFIC SERVICES, INC.
2| Date | Classification | Office | Project area |
|---|---|---|---|
| January 13, 2014 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| October 19, 2011 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for EXACT SCIENTIFIC SERVICES, INC.
- FDA Inspection 865229 - 2014-01-13
- FDA Inspection 752390 - 2011-10-19
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.