Pharmaceutics International, Inc.
Form 483 issued September 29, 2021 · Cockeysville, Maryland
- Inspection
- Jul 26 – Sep 29, 2021
- Investigators
- Kathleen M. Jordan· Marcellinus D. Dordunoo· Shirshendu K. Deb
- Observations
- 10
- Pages
- 15
- FEI number
- 3006503102
In short: On September 29, 2021, FDA issued a Form 483 with 10 observations to Pharmaceutics International, Inc. in Cockeysville, Maryland (FEI 3006503102) after an inspection that ran Jul 26 – Sep 29, 2021. The investigators were Kathleen M. Jordan, Marcellinus D. Dordunoo, Shirshendu K. Deb and Viviana Matta. Most observations concern facilities & equipment and quality system; the most-cited regulation is 21 CFR 211.42 (design and construction features).
At a glance
6 of 10 observations on this 483 concern facilities & equipment.
Most cited: 21 CFR 211.42 (3×) · 211.68 (2×)
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 any unexplained discrepancy and the failure of a batch…
- 02
The responsibilities and procedures applicable to the quality control unit…
- 03
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not…
- 04
Appropriate controls are not exercised over computers or related systems to assure that changes in master…
This inspection in context
Kathleen M. Jordan
6 documents · 2021–2023
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in Maryland.
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, quality system and production. 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.?
Kathleen M. Jordan, Marcellinus D. Dordunoo, Shirshendu K. Deb and Viviana Matta are named on this Form 483, for the inspection of Jul 26 – Sep 29, 2021. Each investigator has a profile showing what they cite most.
When was Pharmaceutics International, Inc. inspected by FDA?
The inspection ran Jul 26 – Sep 29, 2021, and the Form 483 is dated September 29, 2021.
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.