FDA Inspection
Macleods Pharmaceuticals LimitedMacleods Pharmaceuticals Limited – FDA Inspection, Nov 24, 2017
Record Details
This FDA Inspection record concerns Macleods Pharmaceuticals Limited, with an inspection on November 24, 2017, issued by the Center for Drug Evaluation and Research, covering drugs.
View Company Profile
ID · 5666158b-ece5-4f6f-9ecb-028dc4c46aa6
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1032020
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
9- 21 CFR 211.110(a)Control procedures to monitor and validate performance
- 21 CFR 211.25(a)Training--operations, GMPs, written procedures
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.194(a)(4)Complete Test Data
- 21 CFR 211.198(a)Complaint Handling Procedure
- 21 CFR 211.84(b)Representative Samples
- 21 CFR 211.170(b)Annual visual exams of drug products
- 21 CFR 211.100(a)Absence of Written Procedures
- 21 CFR 211.192Investigations of discrepancies, failures
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Macleods Pharmaceuticals Limited
5| Date | Classification | Office | Project area |
|---|---|---|---|
| October 20, 2023 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| November 1, 2021 | OAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| May 15, 2015 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| February 22, 2013 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| December 10, 2010 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Macleods Pharmaceuticals Limited
- FDA Inspection 1220834 - 2023-10-20
- FDA Inspection 1157334 - 2021-11-01
- FDA Inspection 926324 - 2015-05-15
- FDA Inspection 833839 - 2013-02-22
- FDA Inspection 701340 - 2010-12-10
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.