Town and Country Compounding and Consultation Services, LLC
Form 483 issued December 11, 2018 · Ridgewood, New Jersey
- Inspection
- Dec 3, 2018
- Investigator
- Rachael Moliver
- Observations
- 3
- Pages
- 4
- FEI number
- 3006141618
In short: On December 11, 2018, FDA issued a Form 483 with 3 observations to Town and Country Compounding and Consultation Services, LLC in Ridgewood, New Jersey (FEI 3006141618) after an inspection that ran Dec 3, 2018. The investigator was Rachael Moliver. Most observations concern facilities & equipment; the most-cited regulation is 21 CFR 211.42 (design and construction features).
At a glance
Observations span 1 system, led by facilities & equipment.
Most cited: FDCA 501(a)(2)(A) (2×) · 211.42 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01FDCA 501(a)(2)(A)
You did not make adequate product evaluation and take remedial action where actionable microbial contamination was…
- 02
Pressure differentials between areas with different air classifications were not monitored prior or…
- 03FDCA 501(a)(2)(A)
Non-microbial contamination was observed in…
This inspection in context
Rachael Moliver
13 documents · 2016–2020
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in New York.
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 211.42
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 3 observations on this Form 483, mostly about facilities & equipment. The most-cited regulation is 21 CFR 211.42 (design and construction features). The opening words of each observation are shown on this page.
Who inspected Town and Country Compounding and Consultation Services, LLC?
Rachael Moliver is named on this Form 483, for the inspection of Dec 3, 2018. 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 Dec 3, 2018, and the Form 483 is dated December 11, 2018.
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.