Samson Pharmaceuticals, Inc.
Form 483 issued March 25, 2016 · Commerce, California
- Inspection
- Mar 21 – Mar 25, 2016
- Investigator
- Gam S. Zamil
- Observations
- 5
- Pages
- 2
- FEI number
- 3005644727
In short: On March 25, 2016, FDA issued a Form 483 with 5 observations to Samson Pharmaceuticals, Inc. in Commerce, California (FEI 3005644727) after an inspection that ran Mar 21 – Mar 25, 2016. The investigator was Gam S. Zamil. Most observations concern quality system and facilities & equipment; the most-cited regulation is 21 CFR 211.180 (general requirements).
At a glance
4 of 5 observations on this 483 concern quality system.
Most cited: 21 CFR 211.180 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Page I of 4 Pagc(s) The procedures for the (b) (4) quality standards record evaluation are…
- 02
The quality control unit lacks the responsibility and authority to approve and reject all components, drug…
- 03
Routine checking of automatic, mechanical, and electronic equipment is not perfonned according to a written program…
- 04
Records associated with drug product components and within the retention ~riod for such records, were not…
This inspection in context
Gam S. Zamil
18 documents · 2016–2024
Cites 211.166 (stability testing) more than any other section. Most of their documents are for sites in New York.
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 211.180
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Samson Pharmaceuticals, Inc.?
FDA listed 5 observations on this Form 483, mostly about quality system and facilities & equipment. The most-cited regulation is 21 CFR 211.180 (general requirements). The opening words of each observation are shown on this page.
Who inspected Samson Pharmaceuticals, Inc.?
Gam S. Zamil is named on this Form 483, for the inspection of Mar 21 – Mar 25, 2016. Each investigator has a profile showing what they cite most.
When was Samson Pharmaceuticals, Inc. inspected by FDA?
The inspection ran Mar 21 – Mar 25, 2016, and the Form 483 is dated March 25, 2016.
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.