Form 483

Reproductive Medicine Associates Of Philadelphia, P.c. Form 483, 2009-12-09

FDA issued a Form 483 to Reproductive Medicine Associates Of Philadelphia, P.c. on 2009-12-09 with 2 public-safe observations.

483· Form 483 issued2 observations

Reproductive Medicine Associates Of Philadelphia, P.c. · Philadelphia, United States · Issued December 9, 2009

Overview

2 public-safe observations are available for this inspection.
2 structured CFR citations are represented.
2 investigators are tied to this Form 483.

Inspectional observations

Each observation cites the regulation FDA found the firm out of compliance with.

9 Dec 2009

21 CFR 1271.47(a)

Procedures for all other requirements

Cited by Gayle S Lawson, Linda M Hoover

9 Dec 2009

21 CFR 1271.80(b)

Specimen collections not timely

Cited by Gayle S Lawson, Linda M Hoover

Inspected site

RMReproductive Medicine Associates Of Philadelphia, P.c.Philadelphia, United States

Inspection team

GSGayle S Lawson

LMLinda M Hoover

Cited regulations

CFR citations associated with this Form 483.

Citation	What it covers	Cited
21 CFR 1271.47(a)	Cited across public-safe Form 483 observations	1x
21 CFR 1271.80(b)	Cited across public-safe Form 483 observations	1x

Full 483 report

Get the verbatim text of all 2 observations

Every observation in full, so your team sees exactly what was cited and how it was answered.

The site's full inspection history around this Form 483
Whether these citations escalated to a warning letter
The investigators involved and the citations they repeat elsewhere