Syenz Laboratory, LLC
Form 483 issued March 5, 2020 · Norwood, New Jersey
- Inspection
- Feb 13 – Mar 5, 2020
- Investigator
- Helen Verdel
- Observations
- 8
- Pages
- 6
- FEI number
- 3011196914
In short: On March 5, 2020, FDA issued a Form 483 with 8 observations to Syenz Laboratory, LLC in Norwood, New Jersey (FEI 3011196914) after an inspection that ran Feb 13 – Mar 5, 2020. The investigator was Helen Verdel. Most observations concern laboratory controls and quality system; the most-cited regulation is 21 CFR 211.160 (general requirements).
At a glance
Laboratory controls and quality system account for 6 of 8 observations.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
The quality control unit lacks authority to review production records to assure that…
- 02
The distribution system is deficient in that each lot of drug product cannot be readily determined…
- 03
Procedures describing the handling of all written and oral complaints regarding a drug product are…
- 04
Each component is not tested for conformity with all appropriate written specifications for purity…
This inspection in context
Helen Verdel
13 documents · 2015–2023
Cites 211.67 (equipment cleaning and maintenance) more than any other section. Most of their documents are for sites in New Jersey.
The firmSyenz Laboratory, LLC history
The site's inspection history, in date order.
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 Syenz Laboratory, LLC?
FDA listed 8 observations on this Form 483, mostly about laboratory controls, quality system and materials. The most-cited regulation is 21 CFR 211.160 (general requirements). The opening words of each observation are shown on this page.
Who inspected Syenz Laboratory, LLC?
Helen Verdel is named on this Form 483, for the inspection of Feb 13 – Mar 5, 2020. Each investigator has a profile showing what they cite most.
When was Syenz Laboratory, LLC inspected by FDA?
The inspection ran Feb 13 – Mar 5, 2020, and the Form 483 is dated March 5, 2020.
How do I get the full Form 483 for Syenz Laboratory, LLC?
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.