Enclara Pharmacia Inc.
Form 483 issued June 6, 2016 · Shar on Hill, Pennsylvania
- Inspection
- Jun 1 – Jun 6, 2016
- Investigator
- Thomas E. Friel
- Observations
- 3
- Pages
- 2
- FEI number
- 3012188803
In short: On June 6, 2016, FDA issued a Form 483 with 3 observations to Enclara Pharmacia Inc. in Shar on Hill, Pennsylvania (FEI 3012188803) after an inspection that ran Jun 1 – Jun 6, 2016. The investigator was Thomas E. Friel. Most observations concern facilities & equipment and production; the most-cited regulation is 21 CFR 211.42 (design and construction features).
At a glance
2 of 3 observations on this 483 concern facilities & equipment.
What FDA observed
Preview: the opening words of each observation- 01
Aseptic processing areas are deficient regarding the system…
- 02
Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the room…
- 03
Clothing of personnel engaged in the processing of drug products is not appropriate for…
This inspection in context
Thomas E. Friel
13 documents · 2013–2017
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in Pennsylvania.
The firmEnclara Pharmacia 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(c)(10)(iv)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Enclara Pharmacia Inc.?
FDA listed 3 observations on this Form 483, mostly about facilities & equipment 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 Enclara Pharmacia Inc.?
Thomas E. Friel is named on this Form 483, for the inspection of Jun 1 – Jun 6, 2016. Each investigator has a profile showing what they cite most.
When was Enclara Pharmacia Inc. inspected by FDA?
The inspection ran Jun 1 – Jun 6, 2016, and the Form 483 is dated June 6, 2016.
How do I get the full Form 483 for Enclara Pharmacia 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.