Pharmaceutics International, Inc.
Form 483 issued November 14, 2022 · Cockeysville, Maryland
- Inspection
- May 10 – Nov 14, 2022
- Investigators
- Bijoy Panicker· Christina K. Theodorou· Erik W. Koester
- Observations
- 10
- Pages
- 10
- FEI number
- 3006503102
In short: On November 14, 2022, FDA issued a Form 483 with 10 observations to Pharmaceutics International, Inc. in Cockeysville, Maryland (FEI 3006503102) after an inspection that ran May 10 – Nov 14, 2022. The investigators were Bijoy Panicker, Christina K. Theodorou, Erik W. Koester, Jonah S. Ufferfilge, Kristina L. Conroy, Rachael O. Oyewole, Robert J. Martin, Simone E. Pitts and Vivin George. Most observations concern facilities & equipment and production; the most-cited regulation is 21 CFR 211.42 (design and construction features).
At a glance
Facilities & equipment and production account for 7 of 10 observations.
Most cited: 21 CFR 211.42 (3×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
There is a failure to thoroughly review the failure of a batch or any of its…
- 02
Aseptic processing areas are deficient regarding systems for maintaining any equipment used to…
- 03
EMPLOYEE®) SIGNATURE DATEISSUED Procedures designed to prevent microbiological contamination of drug products purporting to be…
- 04
Aseptic processing areas are deficient regarding the system…
This inspection in context
Bijoy Panicker
34 documents · 2017–2025
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in New York.
The firmPharmaceutics International, Inc. history
All 7 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.42
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Pharmaceutics International, Inc.?
FDA listed 10 observations on this Form 483, mostly about facilities & equipment, production and quality system. The most-cited regulation is 21 CFR 211.42 (design and construction features). The opening words of each observation are shown on this page.
Who inspected Pharmaceutics International, Inc.?
Bijoy Panicker, Christina K. Theodorou, Erik W. Koester, Jonah S. Ufferfilge, Kristina L. Conroy, Rachael O. Oyewole, Robert J. Martin, Simone E. Pitts and Vivin George are named on this Form 483, for the inspection of May 10 – Nov 14, 2022. Each investigator has a profile showing what they cite most.
When was Pharmaceutics International, Inc. inspected by FDA?
The inspection ran May 10 – Nov 14, 2022, and the Form 483 is dated November 14, 2022.
How do I get the full Form 483 for Pharmaceutics International, Inc.?
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.