13 PHARMACEUTICALS LLC
Form 483 issued February 22, 2022 · Warminster, Pennsylvania
- Inspection
- Feb 7 – Feb 22, 2022
- Investigators
- Daniel J. Min· David A. Oluwo
- Observations
- 5
- Pages
- 8
- FEI number
- 3012763653
In short: On February 22, 2022, FDA issued a Form 483 with 5 observations to 13 PHARMACEUTICALS LLC in Warminster, Pennsylvania (FEI 3012763653) after an inspection that ran Feb 7 – Feb 22, 2022. The investigators were Daniel J. Min and David A. Oluwo. Most observations concern facilities & equipment and quality system; the most-cited regulation is 21 CFR 211.46 (ventilation, air filtration, air heating and cooling).
At a glance
Facilities & equipment and quality system account for 4 of 5 observations.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Written procedures for cleaning and maintenance fail to include description in sufficient detail of methods…
- 02
Equipment for adequate control over humidity and temperature is not provided when appropriate for the manufacture…
- 03
The responsibilities and procedures applicable to the quality control unit…
- 04
There is a failure to thoroughly review any unexplained discrepancy whether or not the batch…
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 211.67
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at 13 PHARMACEUTICALS LLC?
FDA listed 5 observations on this Form 483, mostly about facilities & equipment, quality system and laboratory controls. The most-cited regulation is 21 CFR 211.46 (ventilation, air filtration, air heating and cooling). The opening words of each observation are shown on this page.
Who inspected 13 PHARMACEUTICALS LLC?
Daniel J. Min and David A. Oluwo are named on this Form 483, for the inspection of Feb 7 – Feb 22, 2022. Each investigator has a profile showing what they cite most.
When was 13 PHARMACEUTICALS LLC inspected by FDA?
The inspection ran Feb 7 – Feb 22, 2022, and the Form 483 is dated February 22, 2022.
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.