Pharmaceutical Manufacturing Research Services, Inc.
Form 483 issued January 20, 2015 · Horsham, Pennsylvania
- Inspection
- Jan 12 – Jan 20, 2015
- Investigator
- Anita R. Michael
- Observations
- 1
- Pages
- 2
In short: On January 20, 2015, FDA issued a Form 483 with 1 observation to Pharmaceutical Manufacturing Research Services, Inc. in Horsham, Pennsylvania after an inspection that ran Jan 12 – Jan 20, 2015. The investigator was Anita R. Michael. Most observations concern laboratory controls; the most-cited regulation is 21 CFR 211.165 (testing and release for distribution).
At a glance
1 of 1 observations on this 483 concern laboratory controls.
Most cited: 21 CFR 211.165 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Acceptance criteria for the sampling and testing conducted by the quality control unit is not adequate…
This inspection in context
Anita R. Michael
18 documents · 2006–2020
Cites 211.192 (production record review) 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 211.165
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 211.165 (testing and release for distribution). The opening words of each observation are shown on this page.
Who inspected Pharmaceutical Manufacturing Research Services, Inc.?
Anita R. Michael is named on this Form 483, for the inspection of Jan 12 – Jan 20, 2015. Each investigator has a profile showing what they cite most.
When was Pharmaceutical Manufacturing Research Services, Inc. inspected by FDA?
The inspection ran Jan 12 – Jan 20, 2015, and the Form 483 is dated January 20, 2015.
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.