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FDA Inspection
•Medical Products Laboratories, Inc.•October 12, 2017

Medical Products Laboratories, Inc. – FDA Inspection, Oct 12, 2017

Record Details

This FDA Inspection record concerns Medical Products Laboratories, Inc., with an inspection on October 12, 2017, issued by the Center for Drug Evaluation and Research, covering drugs.

Company
Medical Products Laboratories, Inc.
Inspection Date
October 12, 2017
Product Type
Drugs
Office
Center for Drug Evaluation and Research
People
  • Alison N. Stieg (FDA Associated Person)
  • Michael A. Taylor (Company Rep)
  • Sam Pepe
View Company Profile

ID · 94b8d7e3-0bc4-4e13-94d0-beb46007b539

Inspection Facts

No Action Indicated (NAI)

No objectionable conditions or practices were found during the inspection.

Inspection number
1028594
FDA center
Human Drugs
Project area
Generic Drug Evaluation
Outcome
Form 483 issued

FDA Citations

8
  1. 21 CFR 211.160(b)Scientifically sound laboratory controls
  2. 21 CFR 211.160(b)(4)Calibration - at intervals, written program, remedial action
  3. 21 CFR 211.160(b)(4)Instruments, apparatus, et. al. not meeting specs
  4. 21 CFR 211.194(a)(3)Statement of Sample Weights and Measures
  5. 21 CFR 211.194(a)(4)Complete Test Data
  6. 21 CFR 211.194(a)(8)Identification of Person Performing Review of Lab Records
  7. 21 CFR 211.194(d)Laboratory equipment calibration records
  8. 21 CFR 211.25(a)Training , Education , Experience overall

Full citation text and observation details available on the Dashboard.

Other FDA inspections of Medical Products Laboratories, Inc.

8
DateClassificationOfficeProject area
October 16, 2025Not classifiedPhiladelphia District OfficeDrug Quality Assurance
July 13, 2023VAICenter for Veterinary MedicineMonitoring of Marketed Animal Drugs, Feed, and Devices
March 13, 2020VAICenter for Drug Evaluation and ResearchDrug Quality Assurance
July 21, 2015VAICenter for Devices and Radiological HealthCompliance: Devices
February 24, 2014VAICenter for Food Safety and Applied NutritionFood Composition, Standards, Labeling and Econ
View all 8 other inspections on the company page
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 935401 - 2015-07-21
  • FDA Inspection 862225 - 2014-02-24

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Contact
New York Office:
370 Jay Street 7th Floor
Brooklyn, NY 11201
Scranton Office:
Scranton Enterprise Center, Suite 217
201 Lackawanna Avenue
Scranton, PA, 18503
🇺🇸+1 917-789-5099
🇪🇺+48 532-447-507
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