Delavau LLC
Form 483 issued April 22, 2016 · Philadelphia, Pennsylvania
- Inspection
- Apr 12 – Apr 22, 2016
- Investigators
- Christina K. Theodorou· Craig D. Zagata· Derek S. Dealy
- Observations
- 10
- Pages
- 7
- FEI number
- 1000135987
In short: On April 22, 2016, FDA issued a Form 483 with 10 observations to Delavau LLC in Philadelphia, Pennsylvania (FEI 1000135987) after an inspection that ran Apr 12 – Apr 22, 2016. The investigators were Christina K. Theodorou, Craig D. Zagata, Derek S. Dealy and Matthew R. Noonan. Most observations concern quality system and production; the most-cited regulation is 21 CFR 211.100 (written procedures; deviations).
At a glance
Quality system and production account for 7 of 10 observations.
Most cited: 21 CFR 211.100 (3×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
An ongoing testing program has not been established to monitor the stability characteristics of APIs and…
- 02
Out-of-specification results are not investigated…
- 03
Annual product quality reviews for APIs do not include a review of results of…
- 04
Deviations from established procedures are…
This inspection in context
Christina K. Theodorou
19 documents · 2016–2026
Cites 211.22 (responsibilities of quality control unit) more than any other section. Most of their documents are for sites in Pennsylvania.
The firmDelavau LLC history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.100
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Delavau LLC?
FDA listed 10 observations on this Form 483, mostly about quality system, production and laboratory controls. The most-cited regulation is 21 CFR 211.100 (written procedures; deviations). The opening words of each observation are shown on this page.
Who inspected Delavau LLC?
Christina K. Theodorou, Craig D. Zagata, Derek S. Dealy and Matthew R. Noonan are named on this Form 483, for the inspection of Apr 12 – Apr 22, 2016. Each investigator has a profile showing what they cite most.
When was Delavau LLC inspected by FDA?
The inspection ran Apr 12 – Apr 22, 2016, and the Form 483 is dated April 22, 2016.
How do I get the full Form 483 for Delavau 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.