Veranova, L.P.
Form 483 issued March 8, 2019 · West Deptford, New Jersey
- Inspection
- Feb 4 – Mar 8, 2019
- Investigator
- Nancy M. Espinal
- Observations
- 8
- Pages
- 9
- FEI number
- 2245277
In short: On March 8, 2019, FDA issued a Form 483 with 8 observations to Veranova, L.P. in West Deptford, New Jersey (FEI 2245277) after an inspection that ran Feb 4 – Mar 8, 2019. The investigator was Nancy M. Espinal. Most observations concern laboratory controls and quality system; the most-cited regulation is 21 CFR 211.194 (laboratory records).
At a glance
Laboratory controls and quality system account for 6 of 8 observations.
Most cited: 21 CFR 211.194 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Equipment is not maintained at appropriate intervals to prevent contamination that would alter the safety, identity…
- 02
Investigations of an unexplained discrepancies did not extend to other drug substances that may have been…
- 03
Written procedures are not followed for evaluations conducted at least annually to review records associated with…
- 04
Established test procedure was…
This inspection in context
Nancy M. Espinal
16 documents · 2016–2022
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in New Jersey.
The firmVeranova, L.P. history
All 3 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.194
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Veranova, L.P.?
FDA listed 8 observations on this Form 483, mostly about laboratory controls, quality system and facilities & equipment. The most-cited regulation is 21 CFR 211.194 (laboratory records). The opening words of each observation are shown on this page.
Who inspected Veranova, L.P.?
Nancy M. Espinal is named on this Form 483, for the inspection of Feb 4 – Mar 8, 2019. Each investigator has a profile showing what they cite most.
When was Veranova, L.P. inspected by FDA?
The inspection ran Feb 4 – Mar 8, 2019, and the Form 483 is dated March 8, 2019.
How do I get the full Form 483 for Veranova, L.P.?
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.