Greer Laboratories, Inc.
Form 483 issued January 15, 2013 · Lenoir, North Carolina
- Inspection
- Jan 15, 2013
- Investigators
- Burnell M. Henry· Cynthia Jim
- Observations
- 10
- Pages
- 9
- FEI number
- 1011574
In short: On January 15, 2013, FDA issued a Form 483 with 10 observations to Greer Laboratories, Inc. in Lenoir, North Carolina (FEI 1011574) after an inspection that ran Jan 15, 2013. The investigators were Burnell M. Henry and Cynthia Jim. Most observations concern quality system and laboratory controls; the most-cited regulation is 21 CFR 211.160 (general requirements).
At a glance
Observations span 4 systems, led by quality system.
Most cited: 21 CFR 211.160 (2×) · 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
Product is not manufactured as described in…
- 02
Laboratory controls do not include scientifically sound and appropriate specifications, standards, sampling plans, and test procedures…
- 03
Out of specification test results are invalidated without determining…
- 04
There is no assurance that required testing is performed on samples that are representative of…
This inspection in context
Burnell M. Henry
22 documents · 2012–2026
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in North Carolina.
The firmGreer Laboratories, Inc. history
All 6 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.160
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Greer Laboratories, Inc.?
FDA listed 10 observations on this Form 483, mostly about quality system, laboratory controls and biologics CGMP. The most-cited regulation is 21 CFR 211.160 (general requirements). The opening words of each observation are shown on this page.
Who inspected Greer Laboratories, Inc.?
Burnell M. Henry and Cynthia Jim are named on this Form 483, for the inspection of Jan 15, 2013. Each investigator has a profile showing what they cite most.
When was Greer Laboratories, Inc. inspected by FDA?
The inspection ran Jan 15, 2013, and the Form 483 is dated January 15, 2013.
How do I get the full Form 483 for Greer Laboratories, 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.