American Family Pharmacy, LLC
Form 483 issued July 8, 2014 · Indianapolis, Indiana
- Inspection
- Jun 16 – Jul 8, 2014
- Investigator
- Robert M. Barbosa
- Observations
- 13
- Pages
- 11
- FEI number
- 3004971302
In short: On July 8, 2014, FDA issued a Form 483 with 13 observations to American Family Pharmacy, LLC in Indianapolis, Indiana (FEI 3004971302) after an inspection that ran Jun 16 – Jul 8, 2014. The investigator was Robert M. Barbosa. Most observations concern quality system and materials.
At a glance
Observations span 4 systems, led by quality system.
What FDA observed
Preview: the opening words of each observation- 01
Batch production and control records do not include complete information relating to the production and…
- 02
Control procedures are not established which monitor the output and validate the performance of those manufacturing…
- 03
Employees are not given training in the particular operations they perform as part of their function…
- 04
Drug product production and control records, are not reviewed and approved by the quality control unit…
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 firmAmerican Family Pharmacy, LLC history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.188
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at American Family Pharmacy, LLC?
FDA listed 13 observations on this Form 483, mostly about quality system, materials and laboratory controls. The opening words of each observation are shown on this page.
Who inspected American Family Pharmacy, LLC?
Robert M. Barbosa is named on this Form 483, for the inspection of Jun 16 – Jul 8, 2014. Each investigator has a profile showing what they cite most.
When was American Family Pharmacy, LLC inspected by FDA?
The inspection ran Jun 16 – Jul 8, 2014, and the Form 483 is dated July 8, 2014.
How do I get the full Form 483 for American Family Pharmacy, 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.