Dercher Enterprises, Inc., DBA Gordon
Form 483 issued September 20, 2023 · Upper Darby, Pennsylvania
- Inspection
- Sep 11 – Sep 20, 2023
- Investigators
- Anastasia M. Shields· Juanita P. Versace
- Observations
- 9
- Pages
- 7
- FEI number
- 2510734
In short: On September 20, 2023, FDA issued a Form 483 with 9 observations to Dercher Enterprises, Inc., DBA Gordon in Upper Darby, Pennsylvania (FEI 2510734) after an inspection that ran Sep 11 – Sep 20, 2023. The investigators were Anastasia M. Shields and Juanita P. Versace. Most observations concern production and materials.
At a glance
Observations span 4 systems, led by production.
What FDA observed
Preview: the opening words of each observation- 01
Your firm failed to establish written procedures for production and process controls designed to assure that…
- 02
The written stability program for drug products does not include reliable…
- 03
Reports of analysis from component suppliers are accepted in lieu of testing each component for conformity…
- 04
The responsibilities and procedures applicable to the quality control unit…
This inspection in context
Anastasia M. Shields
45 documents · 2016–2026
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in India.
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 211.100(a)
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 9 observations on this Form 483, mostly about production, materials and facilities & equipment. The opening words of each observation are shown on this page.
Who inspected Dercher Enterprises, Inc., DBA Gordon?
Anastasia M. Shields and Juanita P. Versace are named on this Form 483, for the inspection of Sep 11 – Sep 20, 2023. Each investigator has a profile showing what they cite most.
When was Dercher Enterprises, Inc., DBA Gordon inspected by FDA?
The inspection ran Sep 11 – Sep 20, 2023, and the Form 483 is dated September 20, 2023.
How do I get the full Form 483 for Dercher Enterprises, Inc., DBA Gordon?
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