FDA Inspection
Linde Gas & Equipment IncFDA Inspection 671091 - Linde Gas & Equipment Inc - July 15, 2010
Record Details
This FDA Inspection record concerns Linde Gas & Equipment Inc, with an inspection on July 15, 2010, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Linde Gas & Equipment Inc
- Inspection Date
- July 15, 2010
- Product Type
- Drugs
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ID · e7506e6a-53e8-4fc5-a9b6-6454f05651a2
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 671091
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
11- 21 CFR 211.137(a)Expiration date lacking
- 21 CFR 211.160(a)Following/documenting laboratory controls
- 21 CFR 211.122(b)Labeling and packaging improperly approved/released
- 21 CFR 211.113(a)Procedures for non-sterile drug products
- 21 CFR 211.125(a)Strict control not exercised over labeling issued
- 21 CFR 211.180(e)(2)Review of problem drugs
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.80(b)Handling and Storage to Prevent Contamination
- 21 CFR 211.42(c)Defined areas of adequate size for operations
- 21 CFR 211.67(b)Written procedures not established/followed
Showing 10 of 11 citations.
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Other FDA inspections of Linde Gas & Equipment Inc
1| Date | Classification | Office | Project area |
|---|---|---|---|
| November 1, 2013 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Linde Gas & Equipment Inc
- FDA Inspection 864484 - 2013-11-01
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