Mandell's Clinical Pharmacy
FDA inspection history in Somerset, New Jersey, 2019 to 2022
- 2
- Form 483s
Every document, by year
- Form 483
2019: one Form 483; 2022: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2019One Form 483, at Somerset, New Jersey.
- 2019The longest 483 on file: 5 observations over 4 pages at Somerset, New Jersey.
- 2022One Form 483, at Somerset, New Jersey.
Cited most
Across all Mandell's Clinical Pharmacy observations on file
- 21 CFR 211.113Control of microbiological contamination5
- 21 CFR 211.42Design and construction features2
- 21 CFR 211.28Personnel responsibilities1
- 21 CFR 211.67Equipment cleaning and maintenance1
The complete Mandell's Clinical Pharmacy file.
All 2 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
The price of the documents, added to your cart together
Sites
Somerset, New Jersey
Two Form 483s · 2019 to 2022 · 9 observations
Latest: Form 483, Jun 17, 2022 →
Documents
2 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2022-06-17 | 483 Form 483 | Somerset, New Jersey | 4 | $99 |
| 2019-07-25 | 483 Form 483 | Somerset, New Jersey | 5 | $99 |
Investigators on these documents
Adetutu Gidado (1)Daniel J. Min (1)Nancy M. Espinal (1)Niketa Patel (1)Sayyem H. Akbar (1)
FEI number 3010924627 · most recent document Jun 17, 2022
About Mandell's Clinical Pharmacy
How many FDA Form 483s has Mandell's Clinical Pharmacy received?
FDA Intel has 2 Form 483s on file for Mandell's Clinical Pharmacy; the most recent is dated Jun 17, 2022.
When was Mandell's Clinical Pharmacy last inspected by FDA?
The most recent FDA inspection document on file for Mandell's Clinical Pharmacy is a Form 483 dated Jun 17, 2022, for the site in Somerset, New Jersey.
What did FDA cite at Mandell's Clinical Pharmacy?
The regulations cited most in the observations on file for Mandell's Clinical Pharmacy are 21 CFR 211.113 (Control of microbiological contamination), 5 times; 21 CFR 211.42 (Design and construction features), 2 times; 21 CFR 211.28 (Personnel responsibilities), 1 time.