FDA Inspection
Meditech Laboratories, IncMeditech Laboratories, Inc – FDA Inspection, Mar 18, 2016
Record Details
This FDA Inspection record concerns Meditech Laboratories, Inc, with an inspection on March 18, 2016, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Meditech Laboratories, Inc
- Inspection Date
- March 18, 2016
- Product Type
- Drugs
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ID · 20575f99-be7e-4c65-b68f-13e078423db2
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 963740
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
13- 21 CFR 211.42(c)(10)(iii)Air Supply
- 21 CFR 211.42(c)(10)(v)Cleaning System
- 21 CFR 211.42(c)(10)(iv)Environmental Monitoring System
- 21 CFR 211.94(b)Protection from external factors
- 21 CFR 211.94(c)Containers & Closures Clean, Sterilized, Pyrogen-free
- 21 CFR 211.192Quality control unit review of records
- 21 CFR 211.137(a)Expiration date lacking
- 21 CFR 211.167(a)Sterility/pyrogen-free testing
- 21 CFR 211.28(a)Protective Apparel Not Worn
- 21 CFR 211.165(a)Testing and release for distribution
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Other FDA inspections of Meditech Laboratories, Inc
1| Date | Classification | Office | Project area |
|---|---|---|---|
| May 11, 2017 | Not classified | San Francisco District Office |
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