Coupler Enterprises
Form 483 issued August 10, 2023 · Horsham, Pennsylvania
- Inspection
- Aug 1 – Aug 10, 2023
- Investigator
- Brandy N. Lepage
- Observations
- 6
- Pages
- 6
- FEI number
- 3003734940
In short: On August 10, 2023, FDA issued a Form 483 with 6 observations to Coupler Enterprises in Horsham, Pennsylvania (FEI 3003734940) after an inspection that ran Aug 1 – Aug 10, 2023. The investigator was Brandy N. Lepage. Most observations concern packaging & labeling and quality system.
At a glance
Observations span 4 systems, led by packaging & labeling.
What FDA observed
Preview: the opening words of each observation- 01
The responsibilities and procedures applicable to the quality control unit…
- 02
The packaging and labeling operation involving cut labels and relying on visual inspection does not provide…
- 03
Equipment used in the manufacture, processing, packing or holding of drug products is not of appropriate…
- 04
Inspection of the facilities immediately before use is not done to assure that all drug products…
This inspection in context
Brandy N. Lepage
31 documents · 2021–2026
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in Pennsylvania.
The firmCoupler Enterprises history
All 3 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.22(d)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Coupler Enterprises?
FDA listed 6 observations on this Form 483, mostly about packaging & labeling, quality system and facilities & equipment. The opening words of each observation are shown on this page.
Who inspected Coupler Enterprises?
Brandy N. Lepage is named on this Form 483, for the inspection of Aug 1 – Aug 10, 2023. Each investigator has a profile showing what they cite most.
When was Coupler Enterprises inspected by FDA?
The inspection ran Aug 1 – Aug 10, 2023, and the Form 483 is dated August 10, 2023.
How do I get the full Form 483 for Coupler Enterprises?
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.