FDA Inspection
TECHNICHEM CORPTECHNICHEM CORP – FDA Inspection, Apr 28, 2025
Record Details
This FDA Inspection record concerns TECHNICHEM CORP, with an inspection on April 28, 2025, issued by the Los Angeles District Office, covering human drugs.
View Company Profile
ID · 5e1613e7-67d2-42a2-bb8e-212f6a60a45a
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1272520
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
8- 21 CFR 211.188Prepared for each batch, include complete information
- 21 CFR 211.63Equipment Design, Size and Location
- 21 CFR 211.84(d)(2)Reports of Analysis (Components)
- 21 CFR 211.165(a)Testing and release for distribution
- 21 CFR 211.22(a)Lack of quality control unit
- 21 CFR 211.166(a)Lack of written stability program
- 21 CFR 211.67(b)Written procedures not established/followed
- 21 CFR 211.100(a)Absence of Written Procedures
Full citation text and observation details available on the Dashboard.
Other FDA inspections of TECHNICHEM CORP
2| Date | Classification | Office | Project area |
|---|---|---|---|
| March 18, 2020 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| March 9, 2018 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for TECHNICHEM CORP
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.