Pharmaceutics International, Inc.
Form 483 issued October 27, 2017 · Cockeysville, Maryland
- Inspection
- Oct 27, 2017
- Investigators
- Jonathan W. Chapman· Marcus A. Ray· Thomas E. Friel
- Observations
- 8
- Pages
- 14
- FEI number
- 3006503102
In short: On October 27, 2017, FDA issued a Form 483 with 8 observations to Pharmaceutics International, Inc. in Cockeysville, Maryland (FEI 3006503102) after an inspection that ran Oct 27, 2017. The investigators were Jonathan W. Chapman, Marcus A. Ray and Thomas E. Friel. Most observations concern production and facilities & equipment; the most-cited regulation is 21 CFR 211.100 (written procedures; deviations).
At a glance
Production and facilities & equipment account for 6 of 8 observations.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Equipment and utensils are not maintained at appropriate intervals to prevent malfunctions that would alter the…
- 02
Aseptic processing areas are deficient regarding the system…
- 03
Appropriate controls are not exercised over computers or related systems to assure that changes in master…
- 04
Equipment used in the manufacture, processing, packing or holding of drug products is not of appropriate…
This inspection in context
Jonathan W. Chapman
11 documents · 2014–2021
Cites 211.100 (written procedures; deviations) more than any other section. Most of their documents are for sites in China.
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 211.67
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Pharmaceutics International, Inc.?
FDA listed 8 observations on this Form 483, mostly about production, facilities & equipment and quality system. The most-cited regulation is 21 CFR 211.100 (written procedures; deviations). The opening words of each observation are shown on this page.
Who inspected Pharmaceutics International, Inc.?
Jonathan W. Chapman, Marcus A. Ray and Thomas E. Friel are named on this Form 483, for the inspection of Oct 27, 2017. Each investigator has a profile showing what they cite most.
When was Pharmaceutics International, Inc. inspected by FDA?
The inspection ran Oct 27, 2017, and the Form 483 is dated October 27, 2017.
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.