Wood's Pharmacy, Inc., dba The Medicine Shoppe
Form 483 issued January 15, 2015 · Boones Mill, Virginia
- Inspection
- Jan 14 – Jan 15, 2015
- Investigators
- Nebil A. Oumer· Tajah L. Blackburn
- Observations
- 8
- Pages
- 4
- FEI number
- 3004580127
In short: On January 15, 2015, FDA issued a Form 483 with 8 observations to Wood's Pharmacy, Inc., dba The Medicine Shoppe in Boones Mill, Virginia (FEI 3004580127) after an inspection that ran Jan 14 – Jan 15, 2015. The investigators were Nebil A. Oumer and Tajah L. Blackburn. Most observations concern laboratory controls and production; the most-cited regulation is 21 CFR 211.160 (general requirements).
At a glance
Laboratory controls and production account for 6 of 8 observations.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Testing and release of drug product for distribution do not include appropriate laboratory determination of satisfactory…
- 02
There is no written testing program designed to assess the stability…
- 03
Laboratory controls do not include the establishment of scientifically sound and appropriate specifications designed to assure…
- 04
Laboratory records do not include complete records of the periodic…
This inspection in context
Nebil A. Oumer
5 documents · 2012–2015
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in Virginia.
The firmWood's Pharmacy, Inc., dba The Medicine Shoppe history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.165
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Wood's Pharmacy, Inc., dba The Medicine Shoppe?
FDA listed 8 observations on this Form 483, mostly about laboratory controls, production and facilities & equipment. The most-cited regulation is 21 CFR 211.160 (general requirements). The opening words of each observation are shown on this page.
Who inspected Wood's Pharmacy, Inc., dba The Medicine Shoppe?
Nebil A. Oumer and Tajah L. Blackburn are named on this Form 483, for the inspection of Jan 14 – Jan 15, 2015. Each investigator has a profile showing what they cite most.
When was Wood's Pharmacy, Inc., dba The Medicine Shoppe inspected by FDA?
The inspection ran Jan 14 – Jan 15, 2015, and the Form 483 is dated January 15, 2015.
How do I get the full Form 483 for Wood's Pharmacy, Inc., dba The Medicine Shoppe?
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.