Ideal Specialty Apothecary, Inc. dba Ideal Pharmacy
Form 483 issued November 18, 2021 · Unio n, New Jersey
- Inspection
- Sep 13 – Nov 18, 2021
- Investigators
- Helen Verdel· Janet A. Rajan
- Observations
- 7
- Pages
- 6
- FEI number
- 3013505558
In short: On November 18, 2021, FDA issued a Form 483 with 7 observations to Ideal Specialty Apothecary, Inc. dba Ideal Pharmacy in Unio n, New Jersey (FEI 3013505558) after an inspection that ran Sep 13 – Nov 18, 2021. The investigators were Helen Verdel and Janet A. Rajan. Most observations concern facilities & equipment and production; the most-cited regulation is 21 CFR 211.113 (control of microbiological contamination).
At a glance
Facilities & equipment and production account for 6 of 7 observations.
Most cited: 21 CFR 211.113 (3×) · 211.42 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Observation 1: scanned text, readable in the full document.
- 02
(Repeat Observation) Media fills were not performed that closely simulate aseptic compounding operations incorporating, as appropriate…
- 03
(Repeat Observation) The ISO-5 classified area is located within a non-classified…
- 04
The final containers/closures used for drug products intended to be sterile were not maintained to ensure…
This inspection in context
Helen Verdel
13 documents · 2015–2023
Cites 211.67 (equipment cleaning and maintenance) more than any other section. Most of their documents are for sites in New Jersey.
The firmIdeal Specialty Apothecary, Inc. dba Ideal Pharmacy history
All 4 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 Ideal Specialty Apothecary, Inc. dba Ideal Pharmacy?
FDA listed 7 observations on this Form 483, mostly about facilities & equipment, production and materials. 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 Ideal Specialty Apothecary, Inc. dba Ideal Pharmacy?
Helen Verdel and Janet A. Rajan are named on this Form 483, for the inspection of Sep 13 – Nov 18, 2021. Each investigator has a profile showing what they cite most.
When was Ideal Specialty Apothecary, Inc. dba Ideal Pharmacy inspected by FDA?
The inspection ran Sep 13 – Nov 18, 2021, and the Form 483 is dated November 18, 2021.
How do I get the full Form 483 for Ideal Specialty Apothecary, Inc. dba Ideal 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.