Greer Laboratories, Inc.
Form 483 issued December 18, 2024 · Lenoir, North Carolina
- Inspection
- Dec 10 – Dec 18, 2024
- Investigator
- Laurel A. Beer
- Observations
- 5
- Pages
- 7
- FEI number
- 1011574
In short: On December 18, 2024, FDA issued a Form 483 with 5 observations to Greer Laboratories, Inc. in Lenoir, North Carolina (FEI 1011574) after an inspection that ran Dec 10 – Dec 18, 2024. The investigator was Laurel A. Beer. Most observations concern facilities & equipment and production.
At a glance
3 of 5 observations on this 483 concern facilities & equipment.
What FDA observed
Preview: the opening words of each observation- 01
processing areas are deficient regarding the system…
- 02
Your firm failed to establish adequate written procedures for production and process controls designed to assure…
- 03
Written procedures are not followed for the cleaning and maintenance of equipment, including | used in…
- 04
Buildings used in the manufacturing and holding of a drug product are not maintained in a…
This inspection in context
Laurel A. Beer
14 documents · 2021–2026
Cites 211.22 (responsibilities of quality control unit) 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 211.42(c)(10)(iv)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Greer Laboratories, Inc.?
FDA listed 5 observations on this Form 483, mostly about facilities & equipment, production and quality system. The opening words of each observation are shown on this page.
Who inspected Greer Laboratories, Inc.?
Laurel A. Beer is named on this Form 483, for the inspection of Dec 10 – Dec 18, 2024. Each investigator has a profile showing what they cite most.
When was Greer Laboratories, Inc. inspected by FDA?
The inspection ran Dec 10 – Dec 18, 2024, and the Form 483 is dated December 18, 2024.
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.