FDA Inspection
Lina Gale Inc.Lina Gale Inc. – FDA Inspection, Nov 30, 2015
Record Details
This FDA Inspection record concerns Lina Gale Inc., with an inspection on November 30, 2015, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Lina Gale Inc.
- Inspection Date
- November 30, 2015
- Product Type
- Drugs
View Company Profile
ID · f3d03f9d-128b-4cb2-8bce-3dd7ef9d9fac
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 950468
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
7- 21 CFR 211.160(b)(3)Acceptance of drug products
- 21 CFR 211.113(a)Procedures for non-sterile drug products
- 21 CFR 211.67(b)(5)Cleaning SOPs/equipment protection
- 21 CFR 211.68(a)Calibration/Inspection/Checking not done
- 21 CFR 211.42(b)Adequate space lacking to prevent mix-ups and contamination
- 21 CFR 211.100(a)Absence of Written Procedures
- 21 CFR 211.180(e)(2)Items to cover on annual reviews
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Lina Gale Inc.
5| Date | Classification | Office | Project area |
|---|---|---|---|
| June 27, 2018 | 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 1060474 - 2018-06-27
- 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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