FDA Inspection
Lina Gale Inc.Lina Gale Inc. – FDA Inspection, Jun 27, 2018
Record Details
This FDA Inspection record concerns Lina Gale Inc., with an inspection on June 27, 2018, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · d2b11d9c-4fa0-4058-b8de-d6423f24533d
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1060474
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
5- 21 CFR 211.68(b)Computer control of master formula records
- 21 CFR 211.63Equipment Design, Size and Location
- 21 CFR 211.68(a)Calibration/Inspection/Checking not done
- 21 CFR 211.100(a)Absence of Written Procedures
- 21 CFR 211.22(d)Procedures not in writing, fully followed
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Other FDA inspections of Lina Gale Inc.
5| Date | Classification | Office | Project area |
|---|---|---|---|
| November 30, 2015 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| April 30, 2013 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| April 30, 2013 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| December 17, 2010 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| March 23, 2010 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Lina Gale Inc.
- FDA Inspection 950468 - 2015-11-30
- FDA Inspection 830611 - 2013-04-30
- FDA Inspection 830607 - 2013-04-30
- FDA Inspection 703480 - 2010-12-17
- FDA Inspection 653383 - 2010-03-23
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