Pharmaceutical Manufacturing Research Services, Inc.
Form 483 issued May 25, 2017 · Horsham, Pennsylvania
- Inspection
- May 22 – May 25, 2017
- Investigators
- Christina K. Theodorou· James M. Mason· Ko U. Min
- Observations
- 1
- Pages
- 2
- FEI number
- 3004752030
In short: On May 25, 2017, FDA issued a Form 483 with 1 observation to Pharmaceutical Manufacturing Research Services, Inc. in Horsham, Pennsylvania (FEI 3004752030) after an inspection that ran May 22 – May 25, 2017. The investigators were Christina K. Theodorou, James M. Mason and Ko U. Min. Most observations concern laboratory controls; the most-cited regulation is 21 CFR 211.160 (general requirements).
At a glance
1 of 1 observations on this 483 concern laboratory controls.
Most cited: 21 CFR 211.160 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Procedures describing the calibration of instruments, apparatus, gauges and recording devices are…
This inspection in context
Christina K. Theodorou
19 documents · 2016–2026
Cites 211.22 (responsibilities of quality control unit) more than any other section. Most of their documents are for sites in Pennsylvania.
The firmPharmaceutical Manufacturing Research Services, Inc. history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.160
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Pharmaceutical Manufacturing Research Services, Inc.?
FDA listed 1 observation on this Form 483, mostly about laboratory controls. The most-cited regulation is 21 CFR 211.160 (general requirements). The opening words of each observation are shown on this page.
Who inspected Pharmaceutical Manufacturing Research Services, Inc.?
Christina K. Theodorou, James M. Mason and Ko U. Min are named on this Form 483, for the inspection of May 22 – May 25, 2017. Each investigator has a profile showing what they cite most.
When was Pharmaceutical Manufacturing Research Services, Inc. inspected by FDA?
The inspection ran May 22 – May 25, 2017, and the Form 483 is dated May 25, 2017.
How do I get the full Form 483 for Pharmaceutical Manufacturing Research Services, 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.