13 PHARMACEUTICALS LLC
Form 483 issued December 21, 2018 · Warminster, Pennsylvania
- Inspection
- Dec 17 – Dec 21, 2018
- Investigator
- Junho Pak
- Observations
- 4
- Pages
- 3
- FEI number
- 3012763653
In short: On December 21, 2018, FDA issued a Form 483 with 4 observations to 13 PHARMACEUTICALS LLC in Warminster, Pennsylvania (FEI 3012763653) after an inspection that ran Dec 17 – Dec 21, 2018. The investigator was Junho Pak. Most observations concern facilities & equipment and laboratory controls.
At a glance
Facilities & equipment and laboratory controls account for 3 of 4 observations.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Routine inspection and checking of mechanical equipment is not performed according to a written program designed…
- 02
Written procedures for cleaning and maintenance fail to include description in sufficient detail of methods, equipment…
- 03
Laboratory controls do not include the establishment of scientifically sound and appropriate test procedures designed to…
- 04
Drug products are not stored under appropriate conditions of temperature and humidity so that their identity…
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 firm13 PHARMACEUTICALS LLC history
All 3 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.68
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at 13 PHARMACEUTICALS LLC?
FDA listed 4 observations on this Form 483, mostly about facilities & equipment, laboratory controls and materials. The opening words of each observation are shown on this page.
Who inspected 13 PHARMACEUTICALS LLC?
Junho Pak is named on this Form 483, for the inspection of Dec 17 – Dec 21, 2018. Each investigator has a profile showing what they cite most.
When was 13 PHARMACEUTICALS LLC inspected by FDA?
The inspection ran Dec 17 – Dec 21, 2018, and the Form 483 is dated December 21, 2018.
How do I get the full Form 483 for 13 PHARMACEUTICALS LLC?
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.