Town and Country Compounding and Consultation Services, LLC
Form 483 issued August 22, 2016 · Ridgewood, New Jersey
- Inspection
- Jul 19, 2016 – Aug 22, 2020
- Investigators
- Liatte Krueger· Nancy F. Scheraga
- Observations
- 7
- Pages
- 6
- FEI number
- 3006141618
In short: On August 22, 2016, FDA issued a Form 483 with 7 observations to Town and Country Compounding and Consultation Services, LLC in Ridgewood, New Jersey (FEI 3006141618) after an inspection that ran Jul 19, 2016 – Aug 22, 2020. The investigators were Liatte Krueger and Nancy F. Scheraga. Most observations concern facilities & equipment and laboratory controls; the most-cited regulation is 21 CFR 211.113 (control of microbiological contamination).
At a glance
Facilities & equipment and laboratory controls account for 5 of 7 observations.
Most cited: 21 CFR 211.113 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Drug products failing to meet established…
- 02
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are…
- 03
Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the room and equipment…
- 04
Each batch of drug product purporting to be sterile and pyrogen-free is not laboratory tested to…
This inspection in context
Liatte Krueger
2 documents · 2016
Cites 211.165 (testing and release for distribution) more than any other section. Most of their documents are for sites in New Jersey.
The firmTown and Country Compounding and Consultation Services, LLC history
All 3 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.113
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Town and Country Compounding and Consultation Services, LLC?
FDA listed 7 observations on this Form 483, mostly about facilities & equipment, laboratory controls and production. The most-cited regulation is 21 CFR 211.113 (control of microbiological contamination). The opening words of each observation are shown on this page.
Who inspected Town and Country Compounding and Consultation Services, LLC?
Liatte Krueger and Nancy F. Scheraga are named on this Form 483, for the inspection of Jul 19, 2016 – Aug 22, 2020. Each investigator has a profile showing what they cite most.
When was Town and Country Compounding and Consultation Services, LLC inspected by FDA?
The inspection ran Jul 19, 2016 – Aug 22, 2020, and the Form 483 is dated August 22, 2016.
How do I get the full Form 483 for Town and Country Compounding and Consultation Services, 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.