Chartwell Pharmaceuticals Carmel, LLC
Form 483 issued February 28, 2018 · Carmel, New York
- Inspection
- Feb 15 – Feb 28, 2018
- Investigator
- Helen B. Ricalde
- Observations
- 2
- Pages
- 4
- FEI number
- 3009686761
In short: On February 28, 2018, FDA issued a Form 483 with 2 observations to Chartwell Pharmaceuticals Carmel, LLC in Carmel, New York (FEI 3009686761) after an inspection that ran Feb 15 – Feb 28, 2018. The investigator was Helen B. Ricalde. Most observations concern quality system and facilities & equipment; the most-cited regulation is 21 CFR 211.198 (complaint files).
At a glance
Quality system and facilities & equipment account for 2 of 2 observations.
Most cited: 21 CFR 211.198(a) (1×) · 211.68(a) (1×)
What FDA observed
Preview: the opening words of each observation- 01
Procedures describing the handling of written and oral complaints related to drug products are…
- 02
Routine checking of equipment is not performed according to a written program designed…
This inspection in context
Helen B. Ricalde
9 documents · 2003–2023
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in New York.
The firmChartwell Pharmaceuticals Carmel, LLC history
All 5 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.198(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Chartwell Pharmaceuticals Carmel, LLC?
FDA listed 2 observations on this Form 483, mostly about quality system and facilities & equipment. The most-cited regulation is 21 CFR 211.198 (complaint files). The opening words of each observation are shown on this page.
Who inspected Chartwell Pharmaceuticals Carmel, LLC?
Helen B. Ricalde is named on this Form 483, for the inspection of Feb 15 – Feb 28, 2018. Each investigator has a profile showing what they cite most.
When was Chartwell Pharmaceuticals Carmel, LLC inspected by FDA?
The inspection ran Feb 15 – Feb 28, 2018, and the Form 483 is dated February 28, 2018.
How do I get the full Form 483 for Chartwell Pharmaceuticals Carmel, 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.