FDA Inspection
LA LabsLA Labs – FDA Inspection, Nov 5, 2010
Record Details
This FDA Inspection record concerns LA Labs, with an inspection on November 5, 2010, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- LA Labs
- Inspection Date
- November 5, 2010
- Product Type
- Drugs
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ID · fb471f1b-7613-4373-a7be-09b79e771c27
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 698565
- FDA center
- Human Drugs
- Project area
- Unapproved and Misbranded Drugs
FDA Citations
12- 21 CFR 211.103Actual vs. theoretical yields not determined
- 21 CFR 211.170(a)Active ingredient retained sample kept
- 21 CFR 211.84(d)(3)Certificates of Testing (Containers, Closures)
- 21 CFR 211.192Quality control unit review of records
- 21 CFR 211.142(b)Storage under appropriate conditions
- 21 CFR 211.80(d)Status of Each Lot Identified
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.194(e)Stability testing records not included
- 21 CFR 211.167(c)Controlled release test methods written, followed
- 21 CFR 211.167(a)Sterility/pyrogens - test methods written, followed
Showing 10 of 12 citations.
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Other FDA inspections of LA Labs
4| Date | Classification | Office | Project area |
|---|---|---|---|
| October 29, 2015 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| April 5, 2013 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| April 8, 2011 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| June 23, 2010 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for LA Labs
- FDA Inspection 946596 - 2015-10-29
- FDA Inspection 826065 - 2013-04-05
- FDA Inspection 720409 - 2011-04-08
- FDA Inspection 671862 - 2010-06-23
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