Ideal Specialty Apothecary, Inc. dba Ideal Pharmacy
Form 483 issued September 29, 2017 · Union, New Jersey
- Inspection
- Jun 19 – Aug 31, 2017
- Investigators
- Emmanuel J. Ramos· Neda Hamandi· Nicholas Violand
- Observations
- 6
- Pages
- 2
- FEI number
- 3013505558
In short: On September 29, 2017, FDA issued a Form 483 with 6 observations to Ideal Specialty Apothecary, Inc. dba Ideal Pharmacy in Union, New Jersey (FEI 3013505558) after an inspection that ran Jun 19 – Aug 31, 2017. The investigators were Emmanuel J. Ramos, Neda Hamandi, Nicholas Violand and Zakaria I. Ganiyu. Most observations concern facilities & equipment and production; the most-cited regulation is 21 CFR 211.113 (control of microbiological contamination).
At a glance
4 of 6 observations on this 483 concern facilities & equipment.
Most cited: 21 CFR 211.113 (2×) · 211.46 (2×)
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 (b)(4) for aseptic filling or repackaging of sterile drug products has a negative pressure…
- 02
Non-sterile cleaning pads are used for initial cleaning of surfaces inside the ISO-5 (b)(4) and we…
- 03
There is no assurance that the ISO-5 (b)(4) is certified under dynamic conditions representative of…
- 04
Media fill studies are performed, but are not designed…
This inspection in context
Emmanuel J. Ramos
9 documents · 2017–2021
Cites 211.192 (production record review) 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 6 observations on this Form 483, mostly about facilities & equipment 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 Ideal Specialty Apothecary, Inc. dba Ideal Pharmacy?
Emmanuel J. Ramos, Neda Hamandi, Nicholas Violand and Zakaria I. Ganiyu are named on this Form 483, for the inspection of Jun 19 – Aug 31, 2017. 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 Jun 19 – Aug 31, 2017, and the Form 483 is dated September 29, 2017.
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.