FDA Inspection
Amaros Co., LtdAmaros Co., Ltd – FDA Inspection, May 12, 2017
Record Details
This FDA Inspection record concerns Amaros Co., Ltd, with an inspection on May 12, 2017, issued by the Center for Drug Evaluation and Research, covering drugs.
View Company Profile
ID · 768661d2-7d7a-49fb-9bbc-91dedfdb27d2
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1014013
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
14- 21 CFR 211.170(a)Active ingredient retained sample kept
- 21 CFR 211.110(a)Control procedures to monitor and validate performance
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.113(a)Procedures for non-sterile drug products
- 21 CFR 211.150(b)Distribution Recall System
- 21 CFR 211.186(a)Signature and checking of records -- 2 persons
- 21 CFR 211.22(a)Contract drug products--lack of responsibility
- 21 CFR 211.100(a)Absence of Written Procedures
- 21 CFR 211.122(a)Written procedures describing in detail
- 21 CFR 211.22(a)Lack of quality control unit
Showing 10 of 14 citations.
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.