Mandell's Clinical Pharmacy
Form 483 issued June 17, 2022 · Somerset, New Jersey
- Inspection
- May 17 – Jun 17, 2022
- Investigators
- Adetutu Gidado· Daniel J. Min· Sayyem H. Akbar
- Observations
- 4
- Pages
- 4
- FEI number
- 3010924627
In short: On June 17, 2022, FDA issued a Form 483 with 4 observations to Mandell's Clinical Pharmacy in Somerset, New Jersey (FEI 3010924627) after an inspection that ran May 17 – Jun 17, 2022. The investigators were Adetutu Gidado, Daniel J. Min and Sayyem H. Akbar. 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 4 observations on this 483 concern production.
Most cited: 21 CFR 211.113 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Media fills were not performed that closely simulate aseptic production operations incorporating, as appropriate, worst-case activities…
- 02
Personnel were observed putting on gowning apparel in a way that may cause the gowning…
- 03
No assurance that sterile drug products were processed and stored under…
- 04
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile do not include…
This inspection in context
Adetutu Gidado
16 documents · 2016–2025
Cites 211.68 (automatic, mechanical, and electronic equipment) 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 4 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?
Adetutu Gidado, Daniel J. Min and Sayyem H. Akbar are named on this Form 483, for the inspection of May 17 – Jun 17, 2022. Each investigator has a profile showing what they cite most.
When was Mandell's Clinical Pharmacy inspected by FDA?
The inspection ran May 17 – Jun 17, 2022, and the Form 483 is dated June 17, 2022.
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.