FDA Inspection
Medical Products Laboratories, Inc.Medical Products Laboratories, Inc. – FDA Inspection, Jun 14, 2010
Record Details
This FDA Inspection record concerns Medical Products Laboratories, Inc., with an inspection on June 14, 2010, issued by the Center for Drug Evaluation and Research, covering drugs.
- Inspection Date
- June 14, 2010
- Product Type
- Drugs
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ID · fe94119c-068b-41d9-8894-ec1c656dfbde
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 667579
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
14- 21 CFR 211.166(b)Adequate number of batches on stability
- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 211.56(a)Sanitation--buildings not clean, free of infestation
- 21 CFR 211.84(c)(2)Containers sampled so as to prevent contamination
- 21 CFR 820.40(a)Document review, approval by designated individual
- 21 CFR 211.63Equipment Design, Size and Location
- 21 CFR 211.113(a)Procedures for non-sterile drug products
- 21 CFR 820.20(c)Management review - Lack of or inadequate procedures
- 21 CFR 820.70(c)Environmental control Lack of or inadequate procedures
- 21 CFR 211.188(a)Accurate reproduction
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Other FDA inspections of Medical Products Laboratories, Inc.
8| Date | Classification | Office | Project area |
|---|---|---|---|
| October 16, 2025 | Not classified | Philadelphia District Office | Drug Quality Assurance |
| July 13, 2023 | VAI | Center for Veterinary Medicine | Monitoring of Marketed Animal Drugs, Feed, and Devices |
| March 13, 2020 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| October 12, 2017 | NAI | Center for Drug Evaluation and Research | Generic Drug Evaluation |
| July 21, 2015 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Medical Products Laboratories, Inc.
- FDA Inspection 1277039 - 2025-10-16
- FDA Inspection 1209945 - 2023-07-13
- FDA Inspection 1120626 - 2020-03-13
- FDA Inspection 1028594 - 2017-10-12
- FDA Inspection 935401 - 2015-07-21
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