13 PHARMACEUTICALS LLC
Form 483 issued March 3, 2023 · Warminster, Pennsylvania
- Investigators
- Daniel J. Min· Janet A. Rajan
- Observations
- 2
- Pages
- 4
- FEI number
- 3012763653
In short: On March 3, 2023, FDA issued a Form 483 with 2 observations to 13 PHARMACEUTICALS LLC in Warminster, Pennsylvania (FEI 3012763653). The investigators were Daniel J. Min and Janet A. Rajan. Most observations concern facilities & equipment; the most-cited regulation is 21 CFR 211.63 (equipment design, size, and location).
At a glance
2 of 2 observations on this 483 concern facilities & equipment.
Most cited: 21 CFR 211.63 (1×) · 211.67 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Equipment used in the manufacture, processing, packing or holding of drug products is not of appropriate…
- 02
Written procedures are not established and followed for the cleaning and maintenance of equipment, including utensils…
This inspection in context
Daniel J. Min
8 documents · 2021–2023
Cites FDCA 501(a)(2)(A) (insanitary conditions) more than any other section. Most of their documents are for sites in Pennsylvania.
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 211.63
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at 13 PHARMACEUTICALS LLC?
FDA listed 2 observations on this Form 483, mostly about facilities & equipment. The most-cited regulation is 21 CFR 211.63 (equipment design, size, and location). The opening words of each observation are shown on this page.
Who inspected 13 PHARMACEUTICALS LLC?
Daniel J. Min and Janet A. Rajan are named on this Form 483. Each investigator has a profile showing what they cite most.
When was 13 PHARMACEUTICALS LLC inspected by FDA?
This Form 483 is dated March 3, 2023.
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.