FDA Inspection
Lofthouse of Fleetwood Ltd.Lofthouse of Fleetwood Ltd. – FDA Inspection, Dec 5, 2014
Record Details
This FDA Inspection record concerns Lofthouse of Fleetwood Ltd., with an inspection on December 5, 2014, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Lofthouse of Fleetwood Ltd.
- Inspection Date
- December 5, 2014
- Product Type
- Drugs
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ID · 6e3e7efd-28da-4f61-8771-b0a8e1fd641a
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 911706
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
8- 21 CFR 211.110(a)Control procedures to monitor and validate performance
- 21 CFR 211.100(b)Procedure Deviations Recorded and Justified
- 21 CFR 211.84(d)(2)Reports of Analysis (Components)
- 21 CFR 211.170(b)Annual visual exams of drug products
- 21 CFR 211.166(a)Results not used for expiration dates, storage cond.
- 21 CFR 211.192Investigations of discrepancies, failures
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.182Written records kept in individual logs
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Other FDA inspections of Lofthouse of Fleetwood Ltd.
2| Date | Classification | Office | Project area |
|---|---|---|---|
| March 22, 2023 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| August 24, 2018 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Lofthouse of Fleetwood Ltd.
- FDA Inspection 1214869 - 2023-03-22
- FDA Inspection 1122378 - 2018-08-24
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