FDA Inspection
Mclaughlin Gormley King CompanyMclaughlin Gormley King Company – FDA Inspection, Dec 8, 2021
Record Details
This FDA Inspection record concerns Mclaughlin Gormley King Company, with an inspection on December 8, 2021, issued by the Center for Drug Evaluation and Research, covering drugs.
- Inspection Date
- December 8, 2021
- Product Type
- Drugs
View Company Profile
ID · 20969a2d-6174-4d37-8c64-63269b1a110c
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1158364
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
2- 21 CFR 211.67(b)Written procedures not established/followed
- 21 CFR 211.80(a)Written Procedures Not Followed
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Mclaughlin Gormley King Company
3| Date | Classification | Office | Project area |
|---|---|---|---|
| November 12, 2015 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| July 30, 2014 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| November 9, 2009 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Mclaughlin Gormley King Company
- FDA Inspection 950797 - 2015-11-12
- FDA Inspection 889103 - 2014-07-30
- FDA Inspection 626858 - 2009-11-09
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.