Reed Pharmacy, Inc.
Form 483 issued September 27, 2018 · Sterling, Kansas
- Inspection
- Sep 24 – Sep 27, 2018
- Investigator
- Robert J. Ham
- Observations
- 5
- Pages
- 3
- FEI number
- 3014522595
In short: On September 27, 2018, FDA issued a Form 483 with 5 observations to Reed Pharmacy, Inc. in Sterling, Kansas (FEI 3014522595) after an inspection that ran Sep 24 – Sep 27, 2018. The investigator was Robert J. Ham. Most observations concern laboratory controls and packaging & labeling; the most-cited regulation is 21 CFR 211.165 (testing and release for distribution).
At a glance
Laboratory controls and packaging & labeling account for 3 of 5 observations.
Most cited: 21 CFR 211.165 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Drug products do not bear an expiration date determined by appropriate stability data to assure they…
- 02
Your firm released drug product in which the strength differs from, or its purity or quality…
- 03
Testing and release of drug products for distribution do not include appropriate laboratory determination of satisfactory…
- 04
Equipment and utensils are not cleaned and sanitized at appropriate intervals to prevent contamination that would…
This inspection in context
Robert J. Ham
32 documents · 2012–2026
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in Missouri.
The firmReed Pharmacy, Inc. 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 Reed Pharmacy, Inc.?
FDA listed 5 observations on this Form 483, mostly about laboratory controls, packaging & labeling and facilities & equipment. The most-cited regulation is 21 CFR 211.165 (testing and release for distribution). The opening words of each observation are shown on this page.
Who inspected Reed Pharmacy, Inc.?
Robert J. Ham is named on this Form 483, for the inspection of Sep 24 – Sep 27, 2018. Each investigator has a profile showing what they cite most.
When was Reed Pharmacy, Inc. inspected by FDA?
The inspection ran Sep 24 – Sep 27, 2018, and the Form 483 is dated September 27, 2018.
How do I get the full Form 483 for Reed 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.