FDA Inspection
Isomers Laboratories Inc.Isomers Laboratories Inc. – FDA Inspection, May 11, 2018
Record Details
This FDA Inspection record concerns Isomers Laboratories Inc., with an inspection on May 11, 2018, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · 30debcaf-b8c4-4c11-8c6d-1272e64f032d
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1054191
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
8- 21 CFR 211.103Actual vs. theoretical yields not determined
- 21 CFR 211.186(b)(9)Complete instructions, procedures, specifications et. al.
- 21 CFR 211.170(b)Annual visual exams of drug products
- 21 CFR 211.160(b)(2)In-process samples representative, identified properly
- 21 CFR 211.100(a)Absence of Written Procedures
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.166(a)(2)Stability sample storage conditions described
- 21 CFR 211.67(b)Written procedures fail to include
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Other FDA inspections of Isomers Laboratories Inc.
3| Date | Classification | Office | Project area |
|---|---|---|---|
| September 25, 2019 | Not classified | Office of Inspections and Investigations | Unapproved and Misbranded Drugs |
| May 29, 2014 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| September 29, 2011 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Isomers Laboratories Inc.
- FDA Inspection 1102733 - 2019-09-25
- FDA Inspection 884454 - 2014-05-29
- FDA Inspection 752282 - 2011-09-29
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