FDA Inspection
Ernest Jackson & Co., Ltd.Ernest Jackson & Co., Ltd. – FDA Inspection, Oct 21, 2022
Record Details
This FDA Inspection record concerns Ernest Jackson & Co., Ltd., with an inspection on October 21, 2022, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Ernest Jackson & Co., Ltd.
- Inspection Date
- October 21, 2022
- Product Type
- Drugs
View Company Profile
ID · e2795e61-1729-43f3-ba07-318e09394a0a
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1181979
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
5- 21 CFR 211.165(b)Microbiological testing
- 21 CFR 211.192Investigations of discrepancies, failures
- 21 CFR 211.42(c)Defined areas of adequate size for operations
- 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 Ernest Jackson & Co., Ltd.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| August 8, 2019 | OAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Ernest Jackson & Co., Ltd.
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.