Village Fertility Pharmacy, Inc.
Form 483 issued March 13, 2013 · Waltham, Massachusetts
- Inspection
- Feb 25 – Mar 13, 2013
- Investigators
- Debra M. Emerson· Philip Kreiter
- Observations
- 4
- Pages
- 3
- FEI number
- 3008335877
In short: On March 13, 2013, FDA issued a Form 483 with 4 observations to Village Fertility Pharmacy, Inc. in Waltham, Massachusetts (FEI 3008335877) after an inspection that ran Feb 25 – Mar 13, 2013. The investigators were Debra M. Emerson and Philip Kreiter. Most observations concern quality system and laboratory controls; the most-cited regulation is 21 CFR 211.192 (production record review).
At a glance
Quality system and laboratory controls account for 3 of 4 observations.
Most cited: 21 CFR 211.192 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Observation 1: scanned text, readable in the full document.
- 02
The firm fai led to adequately evaluate product integrity incident reports, received from patients and healthcare…
- 03
Although the form ula worksheets state that the API and raw materials are non-sterile and the…
- 04
Observation 4: scanned text, readable in the full document.
This inspection in context
Debra M. Emerson
27 documents · 2008–2022
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in Massachusetts.
The firmVillage Fertility Pharmacy, Inc. history
All 3 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.192
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Village Fertility Pharmacy, Inc.?
FDA listed 4 observations on this Form 483, mostly about quality system, laboratory controls and production. The most-cited regulation is 21 CFR 211.192 (production record review). The opening words of each observation are shown on this page.
Who inspected Village Fertility Pharmacy, Inc.?
Debra M. Emerson and Philip Kreiter are named on this Form 483, for the inspection of Feb 25 – Mar 13, 2013. Each investigator has a profile showing what they cite most.
When was Village Fertility Pharmacy, Inc. inspected by FDA?
The inspection ran Feb 25 – Mar 13, 2013, and the Form 483 is dated March 13, 2013.
How do I get the full Form 483 for Village Fertility Pharmacy, 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.