Medical Products Laboratories, Inc
Form 483 issued July 21, 2015 · Philadelphia, Pennsylvania
- Inspection
- Jul 14 – Jul 21, 2015
- Investigator
- Junho Pak
- Observations
- 3
- Pages
- 2
- FEI number
- 2513595
In short: On July 21, 2015, FDA issued a Form 483 with 3 observations to Medical Products Laboratories, Inc in Philadelphia, Pennsylvania (FEI 2513595) after an inspection that ran Jul 14 – Jul 21, 2015. The investigator was Junho Pak. Most observations concern production and laboratory controls.
At a glance
Production and laboratory controls account for 2 of 3 observations.
What FDA observed
Preview: the opening words of each observation- 01
Written production and process control procedures are not followed in the execution of production and process…
- 02
Laboratory controls do not include the establishment of scientifically sound and appropriate standards and test procedures…
- 03
Rejected components and drug product containers are not controlled under a quarantine system designed to prevent…
This inspection in context
Junho Pak
28 documents · 2012–2026
Cites 211.160 (general requirements) more than any other section. Most of their documents are for sites in India.
The firmMedical Products Laboratories, Inc history
All 5 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.100(b)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Medical Products Laboratories, Inc?
FDA listed 3 observations on this Form 483, mostly about production, laboratory controls and materials. The opening words of each observation are shown on this page.
Who inspected Medical Products Laboratories, Inc?
Junho Pak is named on this Form 483, for the inspection of Jul 14 – Jul 21, 2015. Each investigator has a profile showing what they cite most.
When was Medical Products Laboratories, Inc inspected by FDA?
The inspection ran Jul 14 – Jul 21, 2015, and the Form 483 is dated July 21, 2015.
How do I get the full Form 483 for Medical Products Laboratories, Inc?
Download the original PDF from FDA Intel for $99, with no subscription. Your first Form 483 or letter is on us. You also get an invoice PDF with the order.