FDA Inspection
KaryoLogic IncKaryoLogic Inc – FDA Inspection, Dec 19, 2025
Record Details
This FDA Inspection record concerns KaryoLogic Inc, with an inspection on December 19, 2025, issued by the Atlanta District Office, covering animal drugs & feeds.
View Company Profile
ID · fc486c61-65f6-4f15-82c8-5afb1181c0df
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1296070
- FDA center
- Animal Drugs & Feeds
- Project area
- Pre-Approval Evaluation of Animal Drugs and Food Additives
- Outcome
- Form 483 issued
FDA Citations
9- 21 CFR 211.105(b)Distinctive ID or code not recorded in batch record
- 21 CFR 211.160(b)(4)Establishment of calibration procedures
- 21 CFR 211.188Prepared for each batch, include complete information
- 21 CFR 211.194(a)(8)Second person sign off
- 21 CFR 211.194(c)Testing and standardization of standards et. al.
- 21 CFR 211.198(a)Procedures to be written and followed
- 21 CFR 211.22(a)Lack of quality control unit
- 21 CFR 211.25(a)GMP Training Frequency
- 21 CFR 211.67(c)Cleaning/maintenance records not kept
Full citation text and observation details available on the Dashboard.
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.