Main St reet Family Pharmacy, LLC
Form 483 issued June 11, 2013 · Newbern, Tennessee
- Inspection
- May 22 – Jun 11, 2013
- Investigators
- Marvin D. Jones· Samantha J. Bradley
- Observations
- 25
- Pages
- 8
- FEI number
- 3010199183
In short: On June 11, 2013, FDA issued a Form 483 with 25 observations to Main St reet Family Pharmacy, LLC in Newbern, Tennessee (FEI 3010199183) after an inspection that ran May 22 – Jun 11, 2013. The investigators were Marvin D. Jones and Samantha J. Bradley. Most observations concern production and quality system; the most-cited regulation is 21 CFR 211.113 (control of microbiological contamination).
At a glance
Observations span 4 systems, led by production.
Most cited: 21 CFR 211.113(b) (2×)
What FDA observed
Preview: the opening words of each observation- 01
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile do not include…
- 02
Written records of major equipment cleaning, maintenance, and use are not included…
- 03
Equipment and utensils are not cleaned, maintained, and sanitized at appropriate intervals to prevent contamination that…
- 04
There was a failure to handle and store drug product containers at all times in a…
This inspection in context
Marvin D. Jones
22 documents · 2007–2025
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in Mississippi.
The firmMain St reet Family Pharmacy, LLC history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.113(b)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Main St reet Family Pharmacy, LLC?
FDA listed 25 observations on this Form 483, mostly about production, quality system 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 Main St reet Family Pharmacy, LLC?
Marvin D. Jones and Samantha J. Bradley are named on this Form 483, for the inspection of May 22 – Jun 11, 2013. Each investigator has a profile showing what they cite most.
When was Main St reet Family Pharmacy, LLC inspected by FDA?
The inspection ran May 22 – Jun 11, 2013, and the Form 483 is dated June 11, 2013.
How do I get the full Form 483 for Main St reet 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.