PharmaLogic CSP, Inc.
Form 483 issued December 12, 2014 · Bridgep ort, West Virginia
- Inspection
- Dec 8 – Dec 12, 2014
- Investigators
- Doan T. Nguyen· Mujadala M. Abdul-Majid· Rachel C. Harrington
- Observations
- 8
- Pages
- 3
- FEI number
- 3011193301
In short: On December 12, 2014, FDA issued a Form 483 with 8 observations to PharmaLogic CSP, Inc. in Bridgep ort, West Virginia (FEI 3011193301) after an inspection that ran Dec 8 – Dec 12, 2014. The investigators were Doan T. Nguyen, Mujadala M. Abdul-Majid and Rachel C. Harrington. Most observations concern facilities & equipment and production; the most-cited regulation is 21 CFR 211.42 (design and construction features).
At a glance
Observations span 4 systems, led by facilities & equipment.
Most cited: 21 CFR 211.42 (3×) · 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
Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the room and equipment…
- 02
Aseptic processing areas are deficient regarding the system…
- 03
Aseptic processing areas are deficient regarding systems for maintaining any equipment used to…
- 04
Procedures designed to prevent microbiological contamination of drug products purporting to be…
This inspection in context
Doan T. Nguyen
8 documents · 2014–2019
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in Germany.
The firmPharmaLogic CSP, Inc. history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.42
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at PharmaLogic CSP, Inc.?
FDA listed 8 observations on this Form 483, mostly about facilities & equipment, production and laboratory controls. 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 PharmaLogic CSP, Inc.?
Doan T. Nguyen, Mujadala M. Abdul-Majid and Rachel C. Harrington are named on this Form 483, for the inspection of Dec 8 – Dec 12, 2014. Each investigator has a profile showing what they cite most.
When was PharmaLogic CSP, Inc. inspected by FDA?
The inspection ran Dec 8 – Dec 12, 2014, and the Form 483 is dated December 12, 2014.
How do I get the full Form 483 for PharmaLogic CSP, 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.