Samson Pharmaceuticals, Inc.
Form 483 issued January 29, 2020 · Commerce, California
- Inspection
- Jan 29, 2020
- Investigator
- Santiago Gallardo Johnson
- Observations
- 8
- Pages
- 6
- FEI number
- 3005644727
In short: On January 29, 2020, FDA issued a Form 483 with 8 observations to Samson Pharmaceuticals, Inc. in Commerce, California (FEI 3005644727) after an inspection that ran Jan 29, 2020. The investigator was Santiago Gallardo Johnson. Most observations concern facilities & equipment and laboratory controls.
At a glance
Observations span 4 systems, led by facilities & equipment.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
The responsibilities and procedures applicable to the quality control unit…
- 02
Procedures designed to prevent microbiological contamination of drug products purporting to be…
- 03
Equipment and utensils are not maintained at appropriate intervals to prevent contamination that would alter the…
- 04
Aseptic processing areas are deficient in that walls and ceilings are not smooth and/or hard surfaces…
This inspection in context
Santiago Gallardo Johnson
18 documents · 2017–2023
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in California.
The firmSamson Pharmaceuticals, Inc. 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
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Samson Pharmaceuticals, Inc.?
FDA listed 8 observations on this Form 483, mostly about facilities & equipment, laboratory controls and materials. The opening words of each observation are shown on this page.
Who inspected Samson Pharmaceuticals, Inc.?
Santiago Gallardo Johnson is named on this Form 483, for the inspection of Jan 29, 2020. Each investigator has a profile showing what they cite most.
When was Samson Pharmaceuticals, Inc. inspected by FDA?
The inspection ran Jan 29, 2020, and the Form 483 is dated January 29, 2020.
How do I get the full Form 483 for Samson Pharmaceuticals, Inc.?
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.