Dercher Enterprises, Inc., DBA Gordon
Form 483 issued May 4, 2021 · Upper Darby, Pennsylvania
- Inspection
- Apr 19 – May 4, 2021
- Investigators
- Daniel J. Min· David A. Oluwo
- Observations
- 8
- Pages
- 7
- FEI number
- 2510734
In short: On May 4, 2021, FDA issued a Form 483 with 8 observations to Dercher Enterprises, Inc., DBA Gordon in Upper Darby, Pennsylvania (FEI 2510734) after an inspection that ran Apr 19 – May 4, 2021. The investigators were Daniel J. Min and David A. Oluwo. Most observations concern production and laboratory controls.
At a glance
Observations span 4 systems, led by production.
What FDA observed
Preview: the opening words of each observation- 01
There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch…
- 02
There are no written procedures for production and process controls designed to assure that the drug…
- 03
There is no written testing program designed to assess the stability…
- 04
Written procedures for cleaning and maintenance fail to include description in sufficient detail of methods…
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 firmDercher Enterprises, Inc., DBA Gordon history
All 4 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.192
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Dercher Enterprises, Inc., DBA Gordon?
FDA listed 8 observations on this Form 483, mostly about production, laboratory controls and facilities & equipment. The opening words of each observation are shown on this page.
Who inspected Dercher Enterprises, Inc., DBA Gordon?
Daniel J. Min and David A. Oluwo are named on this Form 483, for the inspection of Apr 19 – May 4, 2021. Each investigator has a profile showing what they cite most.
When was Dercher Enterprises, Inc., DBA Gordon inspected by FDA?
The inspection ran Apr 19 – May 4, 2021, and the Form 483 is dated May 4, 2021.
How do I get the full Form 483 for Dercher Enterprises, Inc., DBA Gordon?
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.