Medical Products Laboratories, Inc
Form 483 issued October 12, 2017 · Philadelphia, Pennsylvania
- Inspection
- Oct 2 – Oct 12, 2017
- Investigators
- Alison N. Correll· Michael A. Taylor· Sam Pepe
- Observations
- 8
- Pages
- 9
- FEI number
- 2513595
In short: On October 12, 2017, FDA issued a Form 483 with 8 observations to Medical Products Laboratories, Inc in Philadelphia, Pennsylvania (FEI 2513595) after an inspection that ran Oct 2 – Oct 12, 2017. The investigators were Alison N. Correll, Michael A. Taylor and Sam Pepe. Most observations concern laboratory controls and quality system; the most-cited regulation is 21 CFR 211.194 (laboratory records).
At a glance
7 of 8 observations on this 483 concern laboratory controls.
Most cited: 21 CFR 211.194 (4×) · 211.160 (3×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
The calibration of instruments, apparatus, gauges and recording devices is not…
- 02
Establishment Laboratory records are deficient in that they do not include a complete record of all…
- 03
Laboratory controls do not include the establishment of scientifically sound and appropriate specifications, standards and test…
- 04
Laboratory records are deficient in that they do not include a statement of the weight and…
This inspection in context
Alison N. Correll
1 document · 2017
Cites 211.194 (laboratory records) more than any other section. Most of their documents are for sites in Pennsylvania.
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 211.194
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Medical Products Laboratories, Inc?
FDA listed 8 observations on this Form 483, mostly about laboratory controls and quality system. The most-cited regulation is 21 CFR 211.194 (laboratory records). The opening words of each observation are shown on this page.
Who inspected Medical Products Laboratories, Inc?
Alison N. Correll, Michael A. Taylor and Sam Pepe are named on this Form 483, for the inspection of Oct 2 – Oct 12, 2017. Each investigator has a profile showing what they cite most.
When was Medical Products Laboratories, Inc inspected by FDA?
The inspection ran Oct 2 – Oct 12, 2017, and the Form 483 is dated October 12, 2017.
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.