FDA Inspection
McNeil Healthcare, LLCMcNeil Healthcare, LLC – FDA Inspection, Nov 2, 2010
Record Details
This FDA Inspection record concerns McNeil Healthcare, LLC, with an inspection on November 2, 2010, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- McNeil Healthcare, LLC
- Inspection Date
- November 2, 2010
- Product Type
- Drugs
View Company Profile
ID · 2aaec924-20e4-4374-a6f0-23b46b497ee7
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 695488
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
8- 21 CFR 211.165(f)Failing drug products not rejected
- 21 CFR 211.160(a)Following/documenting laboratory controls
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.166(a)(1)Sample size - test intervals
- 21 CFR 211.110(a)Written in-process control procedures
- 21 CFR 211.67(b)Written procedures fail to include
- 21 CFR 211.100(b)SOPs not followed / documented
- 21 CFR 211.192Written record of investigation incomplete
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Other FDA inspections of McNeil Healthcare, LLC
8| Date | Classification | Office | Project area |
|---|---|---|---|
| September 20, 2023 | VAI | Drug Quality Assurance | |
| March 31, 2021 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| June 21, 2018 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| March 31, 2015 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| August 27, 2013 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for McNeil Healthcare, LLC
- FDA Inspection 1219919 - 2023-09-20
- FDA Inspection 1141017 - 2021-03-31
- FDA Inspection 1060233 - 2018-06-21
- FDA Inspection 921405 - 2015-03-31
- FDA Inspection 847117 - 2013-08-27
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