FDA Inspection
Tomco-Harwel Industries Inc.Tomco-Harwel Industries Inc. – FDA Inspection, Nov 26, 2018
Record Details
This FDA Inspection record concerns Tomco-Harwel Industries Inc., with an inspection on November 26, 2018, issued by the Center for Drug Evaluation and Research, covering drugs.
View Company Profile
ID · acc69129-0fb1-4fc2-9196-11e52b0af46b
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1072597
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
10- 21 CFR 211.188Prepared for each batch, include complete information
- 21 CFR 211.63Equipment Design, Size and Location
- 21 CFR 211.68(a)Calibration/Inspection/Checking not done
- 21 CFR 211.165(a)Testing and release for distribution
- 21 CFR 211.100(a)Absence of Written Procedures
- 21 CFR 211.22(a)Lack of quality control unit
- 21 CFR 211.166(a)Lack of written stability program
- 21 CFR 211.80(a)Procedures To Be in Writing
- 21 CFR 211.67(b)Written procedures not established/followed
- 21 CFR 211.182Written records kept in individual logs
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.