Mandell's Clinical Pharmacy
Form 483 issued July 25, 2019 · Somerset, New Jersey
- Inspection
- Jul 2 – Jul 9, 2019
- Investigators
- Nancy M. Espinal· Niketa Patel
- Observations
- 5
- Pages
- 4
- FEI number
- 3010924627
In short: On July 25, 2019, FDA issued a Form 483 with 5 observations to Mandell's Clinical Pharmacy in Somerset, New Jersey (FEI 3010924627) after an inspection that ran Jul 2 – Jul 9, 2019. The investigators were Nancy M. Espinal and Niketa Patel. Most observations concern production and facilities & equipment; the most-cited regulation is 21 CFR 211.113 (control of microbiological contamination).
At a glance
3 of 5 observations on this 483 concern production.
Most cited: 21 CFR 211.113 (3×)
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
Media fills were not performed that closely simulate aseptic production operations incorporating, as appropriate, worst-case activities…
- 03
Non-depyrogenated equipment was used…
- 04
Disinfectant contact time (also known as "dwell time") and coverage of the item being disinfected were…
This inspection in context
Nancy M. Espinal
16 documents · 2016–2022
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in New Jersey.
The firmMandell's Clinical Pharmacy history
All 2 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 Mandell's Clinical Pharmacy?
FDA listed 5 observations on this Form 483, mostly about production and facilities & equipment. 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 Mandell's Clinical Pharmacy?
Nancy M. Espinal and Niketa Patel are named on this Form 483, for the inspection of Jul 2 – Jul 9, 2019. Each investigator has a profile showing what they cite most.
When was Mandell's Clinical Pharmacy inspected by FDA?
The inspection ran Jul 2 – Jul 9, 2019, and the Form 483 is dated July 25, 2019.
How do I get the full Form 483 for Mandell's Clinical 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.