Greer Laboratories, Inc.
Form 483 issued September 11, 2019 · Lenoir, North Carolina
- Inspection
- Sep 4 – Sep 11, 2019
- Investigator
- Burnell M. Henry
- Observations
- 4
- Pages
- 5
- FEI number
- 1011574
In short: On September 11, 2019, FDA issued a Form 483 with 4 observations to Greer Laboratories, Inc. in Lenoir, North Carolina (FEI 1011574) after an inspection that ran Sep 4 – Sep 11, 2019. The investigator was Burnell M. Henry. Most observations concern production and facilities & equipment.
At a glance
Observations span 3 systems, led by production.
What FDA observed
Preview: the opening words of each observation- 01
Rejected m-process materials are not controlled under a quarantine system to prevent their use in manufacturing…
- 02
Separate or defined areas to prevent contamination or mix-ups are deficient regarding operations related to aseptic…
- 0321 CFR 111.120(c)
Your quality control operations did not nclude conducting a required material review and making a required…
- 04
Your review of corrective action records does not verify that the appropriate corrective…
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 211.110(d)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Greer Laboratories, Inc.?
FDA listed 4 observations on this Form 483, mostly about production, facilities & equipment and dietary supplement CGMP. The opening words of each observation are shown on this page.
Who inspected Greer Laboratories, Inc.?
Burnell M. Henry is named on this Form 483, for the inspection of Sep 4 – Sep 11, 2019. Each investigator has a profile showing what they cite most.
When was Greer Laboratories, Inc. inspected by FDA?
The inspection ran Sep 4 – Sep 11, 2019, and the Form 483 is dated September 11, 2019.
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.