PharMerica LLC
Form 483 issued February 23, 2017 · Indianapolis, Indiana
- Inspection
- Feb 6 – Feb 23, 2017
- Investigators
- Robert M. Barbosa· Sarah E. Rhoades
- Observations
- 8
- Pages
- 4
- FEI number
- 3009215346
In short: On February 23, 2017, FDA issued a Form 483 with 8 observations to PharMerica LLC in Indianapolis, Indiana (FEI 3009215346) after an inspection that ran Feb 6 – Feb 23, 2017. The investigators were Robert M. Barbosa and Sarah E. Rhoades. Most observations concern production and facilities & equipment; the most-cited regulation is 21 CFR 211.113 (control of microbiological contamination).
At a glance
7 of 8 observations on this 483 concern production.
Most cited: 21 CFR 211.113 (7×) · 211.67 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Personnel engaged in aseptic processing were observed with exposed hands…
- 02
Personnel were observed manipulating sterile components outside of…
- 03
Disinfecting agents and cleaning pads or wipes used in the aseptic processing…
- 04
Personnel were observed touching equipment or other surfaces located outside of the ISO 5 area with…
This inspection in context
Robert M. Barbosa
13 documents · 2013–2022
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in Indiana.
The firmPharMerica LLC history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.113
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at PharMerica LLC?
FDA listed 8 observations on this Form 483, mostly about production and facilities & equipment. The most-cited regulation is 21 CFR 211.113 (control of microbiological contamination). The opening words of each observation are shown on this page.
Who inspected PharMerica LLC?
Robert M. Barbosa and Sarah E. Rhoades are named on this Form 483, for the inspection of Feb 6 – Feb 23, 2017. Each investigator has a profile showing what they cite most.
When was PharMerica LLC inspected by FDA?
The inspection ran Feb 6 – Feb 23, 2017, and the Form 483 is dated February 23, 2017.
How do I get the full Form 483 for PharMerica LLC?
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.