Colonia Care Pharmacy
Form 483 issued April 22, 2019 · Colonia, New Jersey
- Inspection
- Mar 26 – Apr 22, 2019
- Investigator
- B. M. Mveng
- Observations
- 3
- Pages
- 3
- FEI number
- 3012223534
In short: On April 22, 2019, FDA issued a Form 483 with 3 observations to Colonia Care Pharmacy in Colonia, New Jersey (FEI 3012223534) after an inspection that ran Mar 26 – Apr 22, 2019. The investigator was B. M. Mveng. Most observations concern facilities & equipment and production; the most-cited regulation is 21 CFR 211.42 (design and construction features).
At a glance
Facilities & equipment and production account for 2 of 3 observations.
Most cited: 21 CFR 211.42 (1×) · 211.113 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
The ISO 5 classified area is located within a non-classified…
- 02
Non-Pharmaceutical grade components are used in the formulation of…
- 03
The use of sporicidal agents in the cleanroom and/or ISO 5 area…
This inspection in context
B. M. Mveng
1 document · 2019
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in New Jersey.
The firmColonia Care Pharmacy history
All 6 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 Colonia Care Pharmacy?
FDA listed 3 observations on this Form 483, mostly about facilities & equipment and production. 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 Colonia Care Pharmacy?
B. M. Mveng is named on this Form 483, for the inspection of Mar 26 – Apr 22, 2019. Each investigator has a profile showing what they cite most.
When was Colonia Care Pharmacy inspected by FDA?
The inspection ran Mar 26 – Apr 22, 2019, and the Form 483 is dated April 22, 2019.
How do I get the full Form 483 for Colonia Care Pharmacy?
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.